Surgical stapler-associated fatalities and adverse events reported to the food and drug administration

Journal of the American College of Surgeons

Volumn 199, Issue 3, 2004, Pages 374-381

  Brown, S Lori ^a,b   Woo, Eileen K ^a  

^a Off Survlnc Biometr Ctr D   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; AUTOMATION; CONTROLLED STUDY; CORRELATION ANALYSIS; DATA BASE; DEVICE REMOVAL; FATALITY; FEMALE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; INFORMATION RETRIEVAL; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; STAPLER; SURGICAL STAPLING; SURGICAL TECHNIQUE;

EQUIPMENT DESIGN; EQUIPMENT FAILURE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; SURGICAL STAPLING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 4344659698     PISSN: 10727515     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jamcollsurg.2004.05.264     Document Type: Article

References (19)

1. Ravitch M.M., Steichen F.M. Staples and staplers. Adv Surg. 17:1984;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. 2004;. Available at: http://www.fda.gov/cdrh/mdr/. Accessed June 19
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. 2004;. Available at: http://www.fda.gov/ora/inspect_ref/iom/ChapterText/800_end.html#SUB800. Accessed June 19
8. Chan D., Bishoff J.T., Ratner L., et al. Endovascular gastrointestinal stapler device malfunction during laparoscopic nephrectomy early recognition and management. J Urol. 164:2000;319-321
9. MacLean L.D., Rhode B.M., Nohr C., et al. Stomal ulcer after gastric bypass. J Am Coll Surg. 185:1997;1-7
10. Yim A.P., Ho K.S. Video-assisted thoracoscopic lobectomy a word of caution. Aust NZ J Surg. 65:1995;438-441
11. Kubba H., Hussain S.S. Stapler failure in pharyngeal diverticulectomy a suggested modification in surgical technique. R Coll Surg Edinb. 43:1998;31-32
12. Read R.C., Ransom J.M. Loose anvil on TA-30 stapler. Ann Thoracic Surg. 30:1980;408-409
13. Hilton M., Brightwell A.P. Oesophageal perforation during stapling of a pharyngeal pouch adverse clinical incident report. J Laryngol Otol. 114:2000;549-550
14. Parer J.G. Pitfalls in using stapler. Med J Aust. 16:1981;537
15. Polglase A.L., Winnett J.D. 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. 36:1993;165-168
17. Hazard Report. Design change leads to premature lockout of Ethicon Endo-Surgery Proximate reloadable linear cutters. Health Devices. 29:2000;374-377
18. Medical Device Recalls. 2004;. Available at: http://www.fda.gov/cdrh/ recalls/. Accessed June 19
19. FDA's Human Factors Program. Promoting safety in medical device use. 2004;. Available at: http://www.fda.gov/cdrh/humanfactors/index.html. Accessed June 19