- Email: [email protected]
Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration1, 212
Surgical Stapler–Associated Fatalities and Adverse Events Reported to the Food and Drug Administration S Lori Brown, PhD, MPH, Eileen K Woo, RN Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure. The Food and Drug Administration (FDA) regulates surgical staplers as a medical device. Manufacturers and health-care providers report adverse events occurring during the use of surgical staplers to the FDA. STUDY DESIGN: Two FDA adverse event databases, the Manufacturer and User Facility Device Experience database and the Alternative Summary Reporting database were searched for adverse events related to the use of surgical staplers. An FDA recall database, Oracle System Center Automated Retrieval, was searched for surgical stapler recalls and the reason for these recalls. RESULTS: We characterized adverse events from 112 death, 2,180 injury, and 22,804 malfunction reports from FDA adverse event databases. We described 22 recalls for these products that are listed in an FDA database. A majority of these recalls were related to manufacturing or design problems. CONCLUSIONS: The overall incidence of these events remains unknown; because these products are used so frequently, even uncommon adverse events may affect many patients. It is important for healthcare providers to report adverse events to manufacturers so that they may work to improve the design of these devices and reduce use errors that contribute to the events. ( J Am Coll Surg 2004;199:374–381. © 2004 by the American College of Surgeons) BACKGROUND:
Surgical staplers and clip appliers are widely used in general surgery to replace conventional sutures.1 Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure.2 They come in a variety of models, including linear and circular ligators, intraluminal and endoscopic staplers, and clip appliers. These devices reportedly diminish trauma by minimizing tissue manipulation and reducing surgical procedure time by ease of
use. For this article, we will refer to all of these devices with the generic term “surgical staplers.” Stapler or clip applier components, such as staples and clips, were also examined. The Food and Drug Administration (FDA) regulates approval or clearance of medical devices, including surgical staplers, and monitors the safety of regulated medical devices through a passive surveillance system. Medical device reporting (MDR) is the mechanism for the FDA to receive significant medical device adverse event reports from manufacturers, importers, and user facilities, so device problems can be detected and corrected quickly. MDR reportable events include death, serious injury, or malfunction.3 Malfunction is defined as the failure of the device to meet its performance specifications or otherwise perform as intended. Malfunctions should be reported to the FDA if the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote. Serious injury is defined as an injury or illness that is life threatening, even if temporary in nature; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or
No competing interests declared.
The opinions or assertions presented herein are the private views of the authors and are not to be construed as conveying either an official endorsement or criticism by the US Department of Health and Human Services, the Public Health Service, or the Food and Drug Administration. Presented at FDA Scientific Forum, Poster Session, Washington, DC, May 2004. Received February 5, 2004; Revised May 11, 2004; Accepted May 12, 2004. From the Epidemiology Branch (Brown) and the Product Evaluation Branch (Woo), Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD. Correspondence address: S Lori Brown, PhD, MPH, FDA Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Postmarket Surveillance, 1350 Piccard Dr, HFZ-541, Rockville, MD 20850.
© 2004 by the American College of Surgeons Published by Elsevier Inc.
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permanent damage to a body structure. Because the manufacturer must decide whether a report is a malfunction or injury, there may be overlap in the types of adverse events in these reports. The FDA also receives voluntary reports on adverse events from health-care providers and consumers through MedWatch, the FDA safety information and adverse event reporting program.4 The FDA received numerous adverse event reports involving surgical stapler use, including deaths, injuries, and malfunctions. We summarized and characterized the reports associated with the use of surgical staplers. We also reviewed an FDA regulatory database that describes product recalls to understand the types of design or manufacturing issues that may contribute to surgical stapler malfunctions, injuries, or deaths. METHODS We retrieved all medical device reports associated with the use of surgical staplers or clip appliers from the Manufacturer and User Facility Device Experience (MAUDE) database received by the FDA by July 1, 2001. MAUDE data consist of all user facility reports since 1991, voluntary reports since June 1993, distributor reports since 1993, and manufacturer reports since August 1996. This database is available for public use on the Internet.5
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when provided (age, gender), procedure in which the device(s) was used, description of the adverse event, patient problem codes, and device problem codes. The patient and device problem codes were obtained from a dictionary that describes the adverse event in terms of the patient (eg, necrosis, pain, additional surgery, etc) or in terms of the device (eg, cutting failure, device failure, component broken, etc). Multiple patient and problem codes may be used to describe an adverse event. We combined similar, related, and overlapping terms (ie, bleeding, hemorrhage, hypovolemic shock, blood transfusion, cardiac tamponade, exsanguination) to summarize death reports. Injury and malfunction reports from MAUDE database
Malfunction and injury reports were examined for the years between 1992 and July 1, 2001. Because of the high volume of reports, we did not review each report. There are several product codes that might have surgical stapler reports mixed in with other devices (endoscope or accessories and laparoscope for general or plastic surgery), but automated searching for surgical stapler reports is not easily accomplished and would require confirmation of reports. For these reasons, we restricted the product codes to surgical staplers (GAG), surgical clip appliers (GDO), implantable clip (FZP), and implantable staples (GDW).
Death reports from MAUDE database
When medical devices are approved or cleared for marketing, a product code is assigned for use when reporting adverse events related to the medical devices. Because of the wide variety of surgical staplers, we reviewed death reports filed with the FDA by July 1, 2001, from several product codes: surgical staplers (GAG), surgical clip appliers (GDO), implantable clip (FZP), and implantable staple (GDW). We also culled death reports on endoscope or accessories (KOG), and laparoscope for general or plastic surgery (GCJ), because we knew that some deaths associated with surgical staplers were reported under these product codes. We reviewed each report, combined duplicate reports (a single incident may be reported by multiple sources), and excluded reports that were not related to surgical staplers. Relevant death reports were exported from MAUDE and entered into a Microsoft Excel spreadsheet. Information abstracted from the report included occupation of the event reporter, patient demographic information
Malfunction reports from Alternative Summary Reporting database
The Center for Devices and Radiological Health has a second adverse event database that includes adverse event reports received through the Alternative Summary Reporting System.6 This system is for reporting malfunctions that are well known and numerous. Instead of submitting individual reports with a description of each adverse event, the manufacturer submits a summary of the problems reported. The FDA accepted alternative summary reports for surgical staplers (GAG) and for surgical clip appliers (GDO) starting in the third quarter of 2001. We used this database to identify additional malfunction reports on surgical staplers reported through October 28, 2003. Product recall database search
We searched the Oracle System Center Automated Retrieval (OSCAR) database for recalls of surgical staplers
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using the product codes for surgical staplers, surgical clip appliers, implantable clips, and implantable staples. We characterized the recalls as being from sterility issues, manufacturing issues, or manufacturing and design issues. Because the database on recalls is not detailed, it is not possible to distinguish between manufacturing and design issues in all cases. When it was not clear, the recall was characterized as “manufacturing/design.” In cases where the text explicitly identified a manufacturing problem, the recall was characterized as “manufacturing.” RESULTS We identified 112 death reports occurring postoperatively when surgical staplers were used. For some operations, multiple staplers were reportedly used. The stapler types reported were linear cutters, linear staplers, endoscopic linear cutters, disposable autosutures, curved intraluminal staplers, articulating linear staplers, and multiclip appliers. In some cases, the stapler type could not be identified from the information provided. Examples of death reports
The following three reports are typical adverse event reports of deaths retrieved from MAUDE. These reports are virtually verbatim and are an indication of the quality of reports the FDA receives. Report 1
A nurse reported this adverse event to the manufacturer in September 1999 after operation on an 83-year-old woman. The instrument cut the tissue, but failed to leave any staples on either side of the cut. The surgeon stated that he transected the superior segment of the right lower lobe of the lung for a mediastinal exploration for hemorrhage. The surgeon also stated the device fired and cut through with the blade but only the first half of the staples deployed. No other staples were found. This was the first firing of the instrument. The patient died. Further followup indicated that earlier in the day, the patient had an aortic valve replacement and three-vessel coronary artery bypass graft. She was transferred to the ICU, where she became hemodynamically unstable and appeared volume dependent. She was returned to the operating room, where it was noted that she had disruption of the visceral pleura of the superior segment of the right lower lung. The etiology of the lung injury was not
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clear to the attending surgeon. Because access was limited through sternotomy, he used peri-strips to bolster the staple line. The instrument fired with the normal “feel”; on release, it had cut, but not deployed staples. After followup, the manufacturer concluded that the surgeon did not use the instrument properly and that the incident was caused by using the instrument with a contraindicated medium (peri-strip, Synovis Life Technologies). Report 2
A physician reported this adverse event to the manufacturer in July 2000. The device was used during a hepatectomy. After the first completed firing, the surgeon reloaded the device and used it to transect the hepatic vein. When the anvil button was released, there was a stream of blood. One side of the triple staggered rows of staples, which was supposed to staple on the hepatic vein, didn’t staple and remained in the cartridge. The patient lost more than 5 L of blood. The case was completed by suturing. Original (involved) device and reload were discarded, but two unused sterile devices from the same lot were returned for analysis. The manufacturer said that no conclusion could be reached based on its analysis of the returned device. Report 3
A risk manager reported this adverse event to the manufacturer in May 2001 after an operation on a 58-yearold woman. The instrument misfired and no staples came out. During wedge resection of the left upper lobe, the patient suffered a massive intraoperative hemorrhage after a malfunction or misfiring of the autosuture device. The patient failed to improve postoperatively and required placement of an intraaortic balloon pump. Life support was withdrawn days later and the patient died. Death report summary
Death reports received by July 1, 2001, were included in this study to characterize adverse events with surgical staplers. The majority of the 112 reports (64%) were filed by health-care professionals (physicians, nurses, pharmacists, bioengineers, and risk managers). All but three of these reports were sent to the surgical stapler manufacturer, which directed them to the FDA in turn. Three were reported directly to the FDA through the MedWatch program. Reporter occupation for the remaining reports was specified as “other” or “unknown.” Patient age, when provided in 56 reports, ranged from
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Table 1. Characteristics of Deaths Reported to the FDA for Surgical Staplers* Through July 2001 Characteristic
Surgical site Gastrointestinal Thoracic Cardiovascular Hepatic, kidney, or spleen Not reported Reported device problems Staples didn’t form Device failure or malfunction Suture line separation or leak Stapler didn’t fire properly† Sticking‡ Other device problems§ Reported patient problems Anastomotic failure Prolonged, additional, or repeated operations Bleeding㛳 Infection¶ Wound dehiscence, leak Other patient problems#
n (total n ⴝ 112)
%
73 21 6
65.2 18.8 5.4
5 7
4.5 6.3
36
32.1
25
22.3
22
19.6
13 7 5
11.6 6.2 4.5
45
40.2
35 33 26 18 35
31.2 29.5 23.2 16.1 31.2
Data were reported between November 1994 and May 2001. *Surgical stapler reports for this table are from the six product codes described in Materials and Methods. † “Stapler didn’t fire” includes problem reports of improper firing, misfiring, failure to fire, or discharge failure. ‡ “Sticking” includes problem reports of sticking, entrapment, or removal difficulty. § “Other device problems” includes application problem, component missing, cutting failure, failure to advance. 㛳 “Bleeding” includes problem reports of bleeding, exsanguinations, hemorrhage, hypovolemic shock, cardiac tamponade, or blood transfusion. ¶ “Infection” includes problem reports of infections, peritonitis, or sepsis. # “Other patient problems” includes problem reports of brain damage, cardiac arrest, contamination of blood by fluid (such as from bowel), embolus, laceration, necrosis, pain, paralysis, perforation, rupture, or tissue damage.
22 through 91 years, with a median age of 70.5 years. In 57 reports, there were 40% female and 60% male patients. We characterized the surgical site and the top five reported device and patient problems. These are summarized in Table 1. The majority of operations were gastrointestinal or pulmonary. Failure of staples to form properly and suture line separation or leak were the most commonly reported problems (Table 1). There were also reports of staplers not firing properly or staplers sticking or being difficult to remove from the tissues. The most
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commonly reported problems for patients were anastomotic failure; prolonged, additional or repeated procedures; and bleeding, including exsanguination (Table 1). Malfunction and injury report summary
Between 1992 and July 1, 2001, the FDA received 2,180 reports of patient injury and 17,687 reports of device malfunctions during surgical stapler use. Figure 1 shows the number of patient injuries and device malfunction reports by year for the MAUDE database. Note that 2001 data were only available for half the year at the time of this analysis. The top five most frequently reported patient problems associated with surgical stapler use were similar for both malfunctions and injuries: anastomotic failure, prolonged or additional procedures, and bleeding (Table 2). Likewise, the most frequently reported device problems included need to replace the device (presumably because of malfunction), staples not forming, sticking, difficulty removing the deployed device from the tissue, and failure to fire and were similar for malfunctions and injury reports (Table 3). Alternative summary reports of surgical stapler malfunctions
Additional reports for 5,117 malfunctioning devices received through the Alternative Summary Reporting System are shown in Table 4. After device failure, “staples not forming” was the most common malfunction reported.
Figure 1. Injury (black) and malfunction (gray) reports by year from the Manufacturer and User Facility Device Experience (MAUDE) database.
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Table 2. Patient Problems Reported in Injury and Malfunction Reports Submitted to the FDA for Surgical Staplers Between 1992 and July 1, 2001
Table 3. Device Problems Reported in Injury and Malfunction Reports Submitted to the FDA for Surgical Staplers Between 1992 and July 1, 2001
Problem
Problem
Injury reports Tissue damage Anastomotic failure Prolonged operation Additional surgical procedure Bleeding Malfunction reports No consequences to patient Anastomotic failure Prolonged operation Additional surgical procedure Bleeding
n
2,180 637 615 469 326 228 17,687 6,796 6,024 505 387 349
% Total
29.2 28.2 21.5 14.9 10.4 38.4 34.0 2.6 2.2 2.0
Surgical stapler reports for this table are from the four product codes described in the Methods section.
Product recalls for surgical staplers and components
n
% Total
2,180 589 426 342 248
27.2 19.5 15.7 11.4
246 157 17,687 7,190 3,166 2,458 2,393 2,219 935
11.3 7.2 40.6 17.9 13.9 13.5 12.5 5.3
Surgical stapler reports for this table are from the four product codes described in the Methods section.
A recall is a company’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers.7 We found 22 recalls related to staplers or stapler components. The reasons for recalls included sterility issues, manufacturing issues, or design/ manufacturing issues (Table 5). The majority of recalls (17) were because of manufacturing or design/ manufacturing issues. Table 4. Device Problems Reported to the FDA for 5,117 Surgical Staplers Through the Alternative Summary Reporting System from July 2001 Through October 28, 2003 Reported device problem
Total*
Difficult to close Component(s) broken Component(s) detached Component(s) worn Component(s) missing Failure to cut Device failure Failure to fire Noise Removal difficulty Failure to retract Slippage Staples did not form Sterility Suture line disruption Total problems reported for 5,119 surgical staplers
14 287 228 1 41 361 2,010 201 3 19 15 4 1,973 1 1 5,159
*Multiple device problems may be reported for a single device.
Injury reports Replace (device was not replaced by another device) Staples did not form Device failure Sticking Removal difficulties (difficulty removing device from tissues) Misfire Malfunction reports Replace Staples did not form Device failure Sticking Misfire Failure to fire
DISCUSSION The Food and Drug Administration received nearly 20,000 malfunction and injury reports for surgical staplers up to July 1, 2001. We reviewed 112 death reports. Death reports described staplers that failed to fire properly during an operation; staples that formed but staple lines ruptured; and staple lines that failed to form properly and were discovered during or after the operation because of deterioration in the patient’s condition. Reports for injuries and malfunctions indicate that similar problems observed in death reports were also responsible for the majority of reports of adverse events that did not lead to a death. This suggests that deaths and injuries might have been prevented if device malfunctions had been prevented. Others have reported adverse events similar to those we observed in the MAUDE database. For instance, Chan and colleagues,8 described 10 cases of endovascular gastrointestinal stapling device failures in a 6-year period involving 565 patients during laparoscopic nephrectomy. Blood loss ranged from 200 to 1,200 mL in these cases. Three malfunctions were attributed to primary instrument failure, and 7 of the 10 failures were reportedly preventable. One study observed that patients with staple line disruption after Roux-en-Y procedures were at greater risk of developing stomal ulcers,
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Table 5. Surgical Stapler Recalls from 1983 to 2003 Product
Sterility Exelok and Absolok Ligating Clips LigaClip DDV Ligator Hemoclip Ligating Clip Appliers Ligaclip Extra Ligating Clip Cartridge Manufacturing PI 55 Urological Surgical Staple
Recall reason
Nonsterile products. The sterility of the device may be compromised from fracture of the blister pack. The ethylene glycol residuals for the lot were too high. Pinhole detected in sterile blister pack. Sterility of the device may be compromised as evidenced by a loss of product integrity.
The recalled cartridge of staples is made for use in a urological surgical procedure. It is desirable for staples to be missing from one end of the cartridge but during production the staples were removed from the wrong end. Wound Clip Applicator Metal ring in the device was manufactured backward and the clip does not release in surgery. Endopath Endoscopic Reloadable Linear Cutters The firm believes a component within the handle was incorrectly molded. Endoscopic clip appliers A portion of the appliers may have rotting, knobs cracking, and/or luer-lock fittings loosening. Manufacturing/Design Disposable EEA Surgical Staples and loading unit Plastic cutting ring may shrink and fall out of place when exposed to subfreezing conditions. Precise Reusable Skin Stapler A piece of the plastic could break from the handle and fall into a wound. Clip Handle Tolerance incompatability between handle and disposable cartridge. Autosuture Stapler may fire without the staples being completely formed into the tissue. Reflex 1 Skin Stapler Incomplete staple closure. Autosuture premium CEEA disposable stapler The anvil head comes off when firing. Autosuture Disposable Stapling Instrument Stapler may not release after firing. Autosuture Signet Disposable Stapler Kits contain stapler that may not release staple after firing. Autosuture Signet Disposable Stapler Kits contain stapler that may not release staple after firing. Surgassist Circular Stapling DLU Does not complete firing cycle. Surgassist Circular Stapling DLU Latching mechanism failure. Ethicon Endosurgery Endopath ETS Flex Articulating Endoscopic Linear Cutter A defective articulation band may result in improper staple formation with possible hematosis. SurgAssist System Circular Stapler DLU Improper staple formation or anvil jam.
indicating the importance of dependable stapling in these techniques.9 We reviewed published case reports and studies that described stapler failure or adverse events related to stapler use.10-14 One author suggested that because the consequences of stapling failure may be serious, physicians should check the stapler before using when possible.15 Another author suggested that most problems encountered with stapling instruments are from use error rather than instrument failure.16 Adverse events may be caused by design flaws in medical devices. An example of this is provided in a publication in the ECRI (formerly Emergency Care Research Institute) journal based, in part, on MDR reports.17 ECRI identified a problem with a design change in the safety lockout assembly on the Ethicon Endo-Surgery Proximate series of reloadable linear cutters, which in-
terfered with the device operation. ECRI detailed changes that the company reported making to mitigate this problem. Product recalls also indicate that stapler problems are not exclusively from use error. A recall is a correction or removal of a product that is defective, could be a risk to health, or is in violation of FDA regulations.18 Most recalls are carried out voluntarily by the manufacturer or distributor of the product. But FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the firm does not recall the product on its own. Our review of recalls for surgical staplers indicated that manufacturing and design issues contributed to problems with surgical staplers. Reported adverse events may be caused by numerous problems, including user inexperience or use error, lot-
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specific manufacturing flaws, fundamental design flaws, or even patient factors, such as tissue friability or disease severity. It is not always possible to distinguish between use error and device failure or design issues. Some research has suggested that the frequency and consequences of medical device use errors may exceed those arising from device failures. So product developers must consider device use and use-related hazards to ensure that their devices will be safe.19 The sheer bulk of adverse events reported to the FDA (more than 20,000 reports), including 112 deaths, is reason for concern. It may be argued that these devices are used so frequently that the incidence of adverse events is relatively small. But because these devices are used frequently, even rare or uncommon problems with the device may affect many patients. Because underreporting is a prominent characteristic of passive reporting systems such as MDR, it is likely that events reported to the FDA underestimate the true extent of the problem. If these adverse events are preventable (ie, caused by use error, inadequate training in device use, patient selection, or device failure from manufacturing or design flaws), then steps should be taken to prevent them. To that end, some potential first steps are to report deaths, injuries, and surgical stapler malfunctions to the manufacturer. Manufacturers are required to review and investigate complaints and use this information to feed back into improving the design and manufacture of their devices. Health-care providers are often unaware of the impact they could have on device design because manufacturers depend on their continued patronage. Physicians, alone or through their professional societies, can work with manufacturers to improve device design to enhance patient safety. They may also work to improve education or training requirements for the appropriate use of surgical staplers and other complex medical devices. Limitations in MDR or MedWatch data should be acknowledged. Device manufacturers, user facilities, and voluntary reporters submit reports to the FDA that are entered into an adverse event database. Accuracy and completeness of reports are not verified by the FDA, and the reports do not establish a causal link between a device and an injury or death. Because all procedures have associated risks independent of the use of surgical staplers, it is not possible to definitively conclude that the reported adverse events are from surgical stapler use.
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Nevertheless, the reports provide an important signal and suggest the need for further investigation into preventing problems associated with surgical stapler use. Author Contributions
Study conception and design: Brown, Woo Acquisition of data: Woo Analysis and interpretation of data: Brown, Woo Drafting of manuscript: Brown Critical revision: Brown, Woo Acknowledgment: We acknowledge the helpful comments and information provided by Michel Gagner, MD, FRCSC, FACS, Chief, Section of Bariatric Surgery, Weill Cornell College of Medicine, New York Presbyterian Hospital, New York, NY, and the CDRH Systematic Technology Assessment of Medical Products workgroup’s comments and information on surgical staplers and on our analysis of Medical Device Reports.
REFERENCES 1. Ravitch MM, Steichen FM. Staples and staplers. Adv Surg 1984; 17:241–279. 2. US Surgical Corporation. Stapling techniques general surgery with Auto Suture® instruments. Copyright 1988. 3. Center for Devices and Radiological Health. Medical Device Reporting. Available at: http://www.fda.gov/cdrh/mdr/. Accessed June 19, 2004. 4. MedWatch, the Safety Information and Adverse Event Reporting System. Available at: http://www.fda.gov/medwatch. Accessed June 19, 2004. 5. Publicly available Manufacturer and User Facility Device Experience database. Available at: http://www.fda.gov/cdrh/ database.html. 6. Guidance for Industry-Medical Device Reporting—Alternative Summary Reporting (ASR) Program. Available at: http:// www.fda.gov/cdrh/osb/guidance/315.html. Accessed June 19, 2004. 7. Investigations Operation Manual. Chapter 8. Recalls. Available at: http://www.fda.gov/ora/inspect_ref/iom/ChapterText/800_end. html#SUB800. Accessed June 19, 2004. 8. Chan D, Bishoff JT, Ratner L, et al. Endovascular gastrointestinal stapler device malfunction during laparoscopic nephrectomy: early recognition and management. J Urol 2000;164: 319–321. 9. MacLean LD, Rhode BM, Nohr C, et al. Stomal ulcer after gastric bypass. J Am Coll Surg 1997;185:1–7. 10. Yim AP, Ho KS. Video-assisted thoracoscopic lobectomy: a word of caution. Aust NZ J Surg 1995;65:438–441. 11. Kubba H, Hussain SS. Stapler failure in pharyngeal diverticulectomy: a suggested modification in surgical technique. R Coll Surg Edinb 1998;43:31–32. 12. Read RC, Ransom JM. Loose anvil on TA-30 stapler. Ann Thoracic Surg 1980;30:408–409. 13. Hilton M, Brightwell AP. Oesophageal perforation during sta-
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pling of a pharyngeal pouch: adverse clinical incident report. J Laryngol Otol 2000;114:549–550. 14. Parer JG. Pitfalls in using stapler. Med J Aust 1981;16:537. 15. Polglase AL, Winnett JD. Check the stapler before use. Aust NZ J Surg 1999;402–403. 16. Bard V, Cohen Z, Ross T. An unusual intraoperative complication of stapled colorectal anastomosis: report of a case and review of the literature. Can J Surg 1993;36:165–168.
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17. Hazard Report. Design change leads to premature lockout of Ethicon Endo-Surgery Proximate reloadable linear cutters. Health Devices 2000;29:374–377. 18. Medical Device Recalls. Available at: http://www.fda.gov/cdrh/ recalls/. Accessed June 19, 2004. 19. FDA’s Human Factors Program. Promoting safety in medical device use. Available at: http://www.fda.gov/cdrh/humanfactors/ index.html. Accessed June 19, 2004.
Surgical staplers and clip appliers are widely used in general surgery to replace conventional sutures.1 Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure.2 They come in a variety of models, including linear and circular ligators, intraluminal and endoscopic staplers, and clip appliers. These devices reportedly diminish trauma by minimizing tissue manipulation and reducing surgical procedure time by ease of
use. For this article, we will refer to all of these devices with the generic term “surgical staplers.” Stapler or clip applier components, such as staples and clips, were also examined. The Food and Drug Administration (FDA) regulates approval or clearance of medical devices, including surgical staplers, and monitors the safety of regulated medical devices through a passive surveillance system. Medical device reporting (MDR) is the mechanism for the FDA to receive significant medical device adverse event reports from manufacturers, importers, and user facilities, so device problems can be detected and corrected quickly. MDR reportable events include death, serious injury, or malfunction.3 Malfunction is defined as the failure of the device to meet its performance specifications or otherwise perform as intended. Malfunctions should be reported to the FDA if the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote. Serious injury is defined as an injury or illness that is life threatening, even if temporary in nature; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or
No competing interests declared.
The opinions or assertions presented herein are the private views of the authors and are not to be construed as conveying either an official endorsement or criticism by the US Department of Health and Human Services, the Public Health Service, or the Food and Drug Administration. Presented at FDA Scientific Forum, Poster Session, Washington, DC, May 2004. Received February 5, 2004; Revised May 11, 2004; Accepted May 12, 2004. From the Epidemiology Branch (Brown) and the Product Evaluation Branch (Woo), Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD. Correspondence address: S Lori Brown, PhD, MPH, FDA Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Division of Postmarket Surveillance, 1350 Piccard Dr, HFZ-541, Rockville, MD 20850.
© 2004 by the American College of Surgeons Published by Elsevier Inc.
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permanent damage to a body structure. Because the manufacturer must decide whether a report is a malfunction or injury, there may be overlap in the types of adverse events in these reports. The FDA also receives voluntary reports on adverse events from health-care providers and consumers through MedWatch, the FDA safety information and adverse event reporting program.4 The FDA received numerous adverse event reports involving surgical stapler use, including deaths, injuries, and malfunctions. We summarized and characterized the reports associated with the use of surgical staplers. We also reviewed an FDA regulatory database that describes product recalls to understand the types of design or manufacturing issues that may contribute to surgical stapler malfunctions, injuries, or deaths. METHODS We retrieved all medical device reports associated with the use of surgical staplers or clip appliers from the Manufacturer and User Facility Device Experience (MAUDE) database received by the FDA by July 1, 2001. MAUDE data consist of all user facility reports since 1991, voluntary reports since June 1993, distributor reports since 1993, and manufacturer reports since August 1996. This database is available for public use on the Internet.5
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when provided (age, gender), procedure in which the device(s) was used, description of the adverse event, patient problem codes, and device problem codes. The patient and device problem codes were obtained from a dictionary that describes the adverse event in terms of the patient (eg, necrosis, pain, additional surgery, etc) or in terms of the device (eg, cutting failure, device failure, component broken, etc). Multiple patient and problem codes may be used to describe an adverse event. We combined similar, related, and overlapping terms (ie, bleeding, hemorrhage, hypovolemic shock, blood transfusion, cardiac tamponade, exsanguination) to summarize death reports. Injury and malfunction reports from MAUDE database
Malfunction and injury reports were examined for the years between 1992 and July 1, 2001. Because of the high volume of reports, we did not review each report. There are several product codes that might have surgical stapler reports mixed in with other devices (endoscope or accessories and laparoscope for general or plastic surgery), but automated searching for surgical stapler reports is not easily accomplished and would require confirmation of reports. For these reasons, we restricted the product codes to surgical staplers (GAG), surgical clip appliers (GDO), implantable clip (FZP), and implantable staples (GDW).
Death reports from MAUDE database
When medical devices are approved or cleared for marketing, a product code is assigned for use when reporting adverse events related to the medical devices. Because of the wide variety of surgical staplers, we reviewed death reports filed with the FDA by July 1, 2001, from several product codes: surgical staplers (GAG), surgical clip appliers (GDO), implantable clip (FZP), and implantable staple (GDW). We also culled death reports on endoscope or accessories (KOG), and laparoscope for general or plastic surgery (GCJ), because we knew that some deaths associated with surgical staplers were reported under these product codes. We reviewed each report, combined duplicate reports (a single incident may be reported by multiple sources), and excluded reports that were not related to surgical staplers. Relevant death reports were exported from MAUDE and entered into a Microsoft Excel spreadsheet. Information abstracted from the report included occupation of the event reporter, patient demographic information
Malfunction reports from Alternative Summary Reporting database
The Center for Devices and Radiological Health has a second adverse event database that includes adverse event reports received through the Alternative Summary Reporting System.6 This system is for reporting malfunctions that are well known and numerous. Instead of submitting individual reports with a description of each adverse event, the manufacturer submits a summary of the problems reported. The FDA accepted alternative summary reports for surgical staplers (GAG) and for surgical clip appliers (GDO) starting in the third quarter of 2001. We used this database to identify additional malfunction reports on surgical staplers reported through October 28, 2003. Product recall database search
We searched the Oracle System Center Automated Retrieval (OSCAR) database for recalls of surgical staplers
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using the product codes for surgical staplers, surgical clip appliers, implantable clips, and implantable staples. We characterized the recalls as being from sterility issues, manufacturing issues, or manufacturing and design issues. Because the database on recalls is not detailed, it is not possible to distinguish between manufacturing and design issues in all cases. When it was not clear, the recall was characterized as “manufacturing/design.” In cases where the text explicitly identified a manufacturing problem, the recall was characterized as “manufacturing.” RESULTS We identified 112 death reports occurring postoperatively when surgical staplers were used. For some operations, multiple staplers were reportedly used. The stapler types reported were linear cutters, linear staplers, endoscopic linear cutters, disposable autosutures, curved intraluminal staplers, articulating linear staplers, and multiclip appliers. In some cases, the stapler type could not be identified from the information provided. Examples of death reports
The following three reports are typical adverse event reports of deaths retrieved from MAUDE. These reports are virtually verbatim and are an indication of the quality of reports the FDA receives. Report 1
A nurse reported this adverse event to the manufacturer in September 1999 after operation on an 83-year-old woman. The instrument cut the tissue, but failed to leave any staples on either side of the cut. The surgeon stated that he transected the superior segment of the right lower lobe of the lung for a mediastinal exploration for hemorrhage. The surgeon also stated the device fired and cut through with the blade but only the first half of the staples deployed. No other staples were found. This was the first firing of the instrument. The patient died. Further followup indicated that earlier in the day, the patient had an aortic valve replacement and three-vessel coronary artery bypass graft. She was transferred to the ICU, where she became hemodynamically unstable and appeared volume dependent. She was returned to the operating room, where it was noted that she had disruption of the visceral pleura of the superior segment of the right lower lung. The etiology of the lung injury was not
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clear to the attending surgeon. Because access was limited through sternotomy, he used peri-strips to bolster the staple line. The instrument fired with the normal “feel”; on release, it had cut, but not deployed staples. After followup, the manufacturer concluded that the surgeon did not use the instrument properly and that the incident was caused by using the instrument with a contraindicated medium (peri-strip, Synovis Life Technologies). Report 2
A physician reported this adverse event to the manufacturer in July 2000. The device was used during a hepatectomy. After the first completed firing, the surgeon reloaded the device and used it to transect the hepatic vein. When the anvil button was released, there was a stream of blood. One side of the triple staggered rows of staples, which was supposed to staple on the hepatic vein, didn’t staple and remained in the cartridge. The patient lost more than 5 L of blood. The case was completed by suturing. Original (involved) device and reload were discarded, but two unused sterile devices from the same lot were returned for analysis. The manufacturer said that no conclusion could be reached based on its analysis of the returned device. Report 3
A risk manager reported this adverse event to the manufacturer in May 2001 after an operation on a 58-yearold woman. The instrument misfired and no staples came out. During wedge resection of the left upper lobe, the patient suffered a massive intraoperative hemorrhage after a malfunction or misfiring of the autosuture device. The patient failed to improve postoperatively and required placement of an intraaortic balloon pump. Life support was withdrawn days later and the patient died. Death report summary
Death reports received by July 1, 2001, were included in this study to characterize adverse events with surgical staplers. The majority of the 112 reports (64%) were filed by health-care professionals (physicians, nurses, pharmacists, bioengineers, and risk managers). All but three of these reports were sent to the surgical stapler manufacturer, which directed them to the FDA in turn. Three were reported directly to the FDA through the MedWatch program. Reporter occupation for the remaining reports was specified as “other” or “unknown.” Patient age, when provided in 56 reports, ranged from
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Table 1. Characteristics of Deaths Reported to the FDA for Surgical Staplers* Through July 2001 Characteristic
Surgical site Gastrointestinal Thoracic Cardiovascular Hepatic, kidney, or spleen Not reported Reported device problems Staples didn’t form Device failure or malfunction Suture line separation or leak Stapler didn’t fire properly† Sticking‡ Other device problems§ Reported patient problems Anastomotic failure Prolonged, additional, or repeated operations Bleeding㛳 Infection¶ Wound dehiscence, leak Other patient problems#
n (total n ⴝ 112)
%
73 21 6
65.2 18.8 5.4
5 7
4.5 6.3
36
32.1
25
22.3
22
19.6
13 7 5
11.6 6.2 4.5
45
40.2
35 33 26 18 35
31.2 29.5 23.2 16.1 31.2
Data were reported between November 1994 and May 2001. *Surgical stapler reports for this table are from the six product codes described in Materials and Methods. † “Stapler didn’t fire” includes problem reports of improper firing, misfiring, failure to fire, or discharge failure. ‡ “Sticking” includes problem reports of sticking, entrapment, or removal difficulty. § “Other device problems” includes application problem, component missing, cutting failure, failure to advance. 㛳 “Bleeding” includes problem reports of bleeding, exsanguinations, hemorrhage, hypovolemic shock, cardiac tamponade, or blood transfusion. ¶ “Infection” includes problem reports of infections, peritonitis, or sepsis. # “Other patient problems” includes problem reports of brain damage, cardiac arrest, contamination of blood by fluid (such as from bowel), embolus, laceration, necrosis, pain, paralysis, perforation, rupture, or tissue damage.
22 through 91 years, with a median age of 70.5 years. In 57 reports, there were 40% female and 60% male patients. We characterized the surgical site and the top five reported device and patient problems. These are summarized in Table 1. The majority of operations were gastrointestinal or pulmonary. Failure of staples to form properly and suture line separation or leak were the most commonly reported problems (Table 1). There were also reports of staplers not firing properly or staplers sticking or being difficult to remove from the tissues. The most
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commonly reported problems for patients were anastomotic failure; prolonged, additional or repeated procedures; and bleeding, including exsanguination (Table 1). Malfunction and injury report summary
Between 1992 and July 1, 2001, the FDA received 2,180 reports of patient injury and 17,687 reports of device malfunctions during surgical stapler use. Figure 1 shows the number of patient injuries and device malfunction reports by year for the MAUDE database. Note that 2001 data were only available for half the year at the time of this analysis. The top five most frequently reported patient problems associated with surgical stapler use were similar for both malfunctions and injuries: anastomotic failure, prolonged or additional procedures, and bleeding (Table 2). Likewise, the most frequently reported device problems included need to replace the device (presumably because of malfunction), staples not forming, sticking, difficulty removing the deployed device from the tissue, and failure to fire and were similar for malfunctions and injury reports (Table 3). Alternative summary reports of surgical stapler malfunctions
Additional reports for 5,117 malfunctioning devices received through the Alternative Summary Reporting System are shown in Table 4. After device failure, “staples not forming” was the most common malfunction reported.
Figure 1. Injury (black) and malfunction (gray) reports by year from the Manufacturer and User Facility Device Experience (MAUDE) database.
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Table 2. Patient Problems Reported in Injury and Malfunction Reports Submitted to the FDA for Surgical Staplers Between 1992 and July 1, 2001
Table 3. Device Problems Reported in Injury and Malfunction Reports Submitted to the FDA for Surgical Staplers Between 1992 and July 1, 2001
Problem
Problem
Injury reports Tissue damage Anastomotic failure Prolonged operation Additional surgical procedure Bleeding Malfunction reports No consequences to patient Anastomotic failure Prolonged operation Additional surgical procedure Bleeding
n
2,180 637 615 469 326 228 17,687 6,796 6,024 505 387 349
% Total
29.2 28.2 21.5 14.9 10.4 38.4 34.0 2.6 2.2 2.0
Surgical stapler reports for this table are from the four product codes described in the Methods section.
Product recalls for surgical staplers and components
n
% Total
2,180 589 426 342 248
27.2 19.5 15.7 11.4
246 157 17,687 7,190 3,166 2,458 2,393 2,219 935
11.3 7.2 40.6 17.9 13.9 13.5 12.5 5.3
Surgical stapler reports for this table are from the four product codes described in the Methods section.
A recall is a company’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers.7 We found 22 recalls related to staplers or stapler components. The reasons for recalls included sterility issues, manufacturing issues, or design/ manufacturing issues (Table 5). The majority of recalls (17) were because of manufacturing or design/ manufacturing issues. Table 4. Device Problems Reported to the FDA for 5,117 Surgical Staplers Through the Alternative Summary Reporting System from July 2001 Through October 28, 2003 Reported device problem
Total*
Difficult to close Component(s) broken Component(s) detached Component(s) worn Component(s) missing Failure to cut Device failure Failure to fire Noise Removal difficulty Failure to retract Slippage Staples did not form Sterility Suture line disruption Total problems reported for 5,119 surgical staplers
14 287 228 1 41 361 2,010 201 3 19 15 4 1,973 1 1 5,159
*Multiple device problems may be reported for a single device.
Injury reports Replace (device was not replaced by another device) Staples did not form Device failure Sticking Removal difficulties (difficulty removing device from tissues) Misfire Malfunction reports Replace Staples did not form Device failure Sticking Misfire Failure to fire
DISCUSSION The Food and Drug Administration received nearly 20,000 malfunction and injury reports for surgical staplers up to July 1, 2001. We reviewed 112 death reports. Death reports described staplers that failed to fire properly during an operation; staples that formed but staple lines ruptured; and staple lines that failed to form properly and were discovered during or after the operation because of deterioration in the patient’s condition. Reports for injuries and malfunctions indicate that similar problems observed in death reports were also responsible for the majority of reports of adverse events that did not lead to a death. This suggests that deaths and injuries might have been prevented if device malfunctions had been prevented. Others have reported adverse events similar to those we observed in the MAUDE database. For instance, Chan and colleagues,8 described 10 cases of endovascular gastrointestinal stapling device failures in a 6-year period involving 565 patients during laparoscopic nephrectomy. Blood loss ranged from 200 to 1,200 mL in these cases. Three malfunctions were attributed to primary instrument failure, and 7 of the 10 failures were reportedly preventable. One study observed that patients with staple line disruption after Roux-en-Y procedures were at greater risk of developing stomal ulcers,
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Table 5. Surgical Stapler Recalls from 1983 to 2003 Product
Sterility Exelok and Absolok Ligating Clips LigaClip DDV Ligator Hemoclip Ligating Clip Appliers Ligaclip Extra Ligating Clip Cartridge Manufacturing PI 55 Urological Surgical Staple
Recall reason
Nonsterile products. The sterility of the device may be compromised from fracture of the blister pack. The ethylene glycol residuals for the lot were too high. Pinhole detected in sterile blister pack. Sterility of the device may be compromised as evidenced by a loss of product integrity.
The recalled cartridge of staples is made for use in a urological surgical procedure. It is desirable for staples to be missing from one end of the cartridge but during production the staples were removed from the wrong end. Wound Clip Applicator Metal ring in the device was manufactured backward and the clip does not release in surgery. Endopath Endoscopic Reloadable Linear Cutters The firm believes a component within the handle was incorrectly molded. Endoscopic clip appliers A portion of the appliers may have rotting, knobs cracking, and/or luer-lock fittings loosening. Manufacturing/Design Disposable EEA Surgical Staples and loading unit Plastic cutting ring may shrink and fall out of place when exposed to subfreezing conditions. Precise Reusable Skin Stapler A piece of the plastic could break from the handle and fall into a wound. Clip Handle Tolerance incompatability between handle and disposable cartridge. Autosuture Stapler may fire without the staples being completely formed into the tissue. Reflex 1 Skin Stapler Incomplete staple closure. Autosuture premium CEEA disposable stapler The anvil head comes off when firing. Autosuture Disposable Stapling Instrument Stapler may not release after firing. Autosuture Signet Disposable Stapler Kits contain stapler that may not release staple after firing. Autosuture Signet Disposable Stapler Kits contain stapler that may not release staple after firing. Surgassist Circular Stapling DLU Does not complete firing cycle. Surgassist Circular Stapling DLU Latching mechanism failure. Ethicon Endosurgery Endopath ETS Flex Articulating Endoscopic Linear Cutter A defective articulation band may result in improper staple formation with possible hematosis. SurgAssist System Circular Stapler DLU Improper staple formation or anvil jam.
indicating the importance of dependable stapling in these techniques.9 We reviewed published case reports and studies that described stapler failure or adverse events related to stapler use.10-14 One author suggested that because the consequences of stapling failure may be serious, physicians should check the stapler before using when possible.15 Another author suggested that most problems encountered with stapling instruments are from use error rather than instrument failure.16 Adverse events may be caused by design flaws in medical devices. An example of this is provided in a publication in the ECRI (formerly Emergency Care Research Institute) journal based, in part, on MDR reports.17 ECRI identified a problem with a design change in the safety lockout assembly on the Ethicon Endo-Surgery Proximate series of reloadable linear cutters, which in-
terfered with the device operation. ECRI detailed changes that the company reported making to mitigate this problem. Product recalls also indicate that stapler problems are not exclusively from use error. A recall is a correction or removal of a product that is defective, could be a risk to health, or is in violation of FDA regulations.18 Most recalls are carried out voluntarily by the manufacturer or distributor of the product. But FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the firm does not recall the product on its own. Our review of recalls for surgical staplers indicated that manufacturing and design issues contributed to problems with surgical staplers. Reported adverse events may be caused by numerous problems, including user inexperience or use error, lot-
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specific manufacturing flaws, fundamental design flaws, or even patient factors, such as tissue friability or disease severity. It is not always possible to distinguish between use error and device failure or design issues. Some research has suggested that the frequency and consequences of medical device use errors may exceed those arising from device failures. So product developers must consider device use and use-related hazards to ensure that their devices will be safe.19 The sheer bulk of adverse events reported to the FDA (more than 20,000 reports), including 112 deaths, is reason for concern. It may be argued that these devices are used so frequently that the incidence of adverse events is relatively small. But because these devices are used frequently, even rare or uncommon problems with the device may affect many patients. Because underreporting is a prominent characteristic of passive reporting systems such as MDR, it is likely that events reported to the FDA underestimate the true extent of the problem. If these adverse events are preventable (ie, caused by use error, inadequate training in device use, patient selection, or device failure from manufacturing or design flaws), then steps should be taken to prevent them. To that end, some potential first steps are to report deaths, injuries, and surgical stapler malfunctions to the manufacturer. Manufacturers are required to review and investigate complaints and use this information to feed back into improving the design and manufacture of their devices. Health-care providers are often unaware of the impact they could have on device design because manufacturers depend on their continued patronage. Physicians, alone or through their professional societies, can work with manufacturers to improve device design to enhance patient safety. They may also work to improve education or training requirements for the appropriate use of surgical staplers and other complex medical devices. Limitations in MDR or MedWatch data should be acknowledged. Device manufacturers, user facilities, and voluntary reporters submit reports to the FDA that are entered into an adverse event database. Accuracy and completeness of reports are not verified by the FDA, and the reports do not establish a causal link between a device and an injury or death. Because all procedures have associated risks independent of the use of surgical staplers, it is not possible to definitively conclude that the reported adverse events are from surgical stapler use.
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Nevertheless, the reports provide an important signal and suggest the need for further investigation into preventing problems associated with surgical stapler use. Author Contributions
Study conception and design: Brown, Woo Acquisition of data: Woo Analysis and interpretation of data: Brown, Woo Drafting of manuscript: Brown Critical revision: Brown, Woo Acknowledgment: We acknowledge the helpful comments and information provided by Michel Gagner, MD, FRCSC, FACS, Chief, Section of Bariatric Surgery, Weill Cornell College of Medicine, New York Presbyterian Hospital, New York, NY, and the CDRH Systematic Technology Assessment of Medical Products workgroup’s comments and information on surgical staplers and on our analysis of Medical Device Reports.
REFERENCES 1. Ravitch MM, Steichen FM. Staples and staplers. Adv Surg 1984; 17:241–279. 2. US Surgical Corporation. Stapling techniques general surgery with Auto Suture® instruments. Copyright 1988. 3. Center for Devices and Radiological Health. Medical Device Reporting. Available at: http://www.fda.gov/cdrh/mdr/. Accessed June 19, 2004. 4. MedWatch, the Safety Information and Adverse Event Reporting System. Available at: http://www.fda.gov/medwatch. Accessed June 19, 2004. 5. Publicly available Manufacturer and User Facility Device Experience database. Available at: http://www.fda.gov/cdrh/ database.html. 6. Guidance for Industry-Medical Device Reporting—Alternative Summary Reporting (ASR) Program. Available at: http:// www.fda.gov/cdrh/osb/guidance/315.html. Accessed June 19, 2004. 7. Investigations Operation Manual. Chapter 8. Recalls. Available at: http://www.fda.gov/ora/inspect_ref/iom/ChapterText/800_end. html#SUB800. Accessed June 19, 2004. 8. Chan D, Bishoff JT, Ratner L, et al. Endovascular gastrointestinal stapler device malfunction during laparoscopic nephrectomy: early recognition and management. J Urol 2000;164: 319–321. 9. MacLean LD, Rhode BM, Nohr C, et al. Stomal ulcer after gastric bypass. J Am Coll Surg 1997;185:1–7. 10. Yim AP, Ho KS. Video-assisted thoracoscopic lobectomy: a word of caution. Aust NZ J Surg 1995;65:438–441. 11. Kubba H, Hussain SS. Stapler failure in pharyngeal diverticulectomy: a suggested modification in surgical technique. R Coll Surg Edinb 1998;43:31–32. 12. Read RC, Ransom JM. Loose anvil on TA-30 stapler. Ann Thoracic Surg 1980;30:408–409. 13. Hilton M, Brightwell AP. Oesophageal perforation during sta-
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pling of a pharyngeal pouch: adverse clinical incident report. J Laryngol Otol 2000;114:549–550. 14. Parer JG. Pitfalls in using stapler. Med J Aust 1981;16:537. 15. Polglase AL, Winnett JD. Check the stapler before use. Aust NZ J Surg 1999;402–403. 16. Bard V, Cohen Z, Ross T. An unusual intraoperative complication of stapled colorectal anastomosis: report of a case and review of the literature. Can J Surg 1993;36:165–168.
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17. Hazard Report. Design change leads to premature lockout of Ethicon Endo-Surgery Proximate reloadable linear cutters. Health Devices 2000;29:374–377. 18. Medical Device Recalls. Available at: http://www.fda.gov/cdrh/ recalls/. Accessed June 19, 2004. 19. FDA’s Human Factors Program. Promoting safety in medical device use. Available at: http://www.fda.gov/cdrh/humanfactors/ index.html. Accessed June 19, 2004.