Laparoscopic linear cutting stapler failure.
OBJECTIVE
To characterize the frequency and nature of problems with linear cutting staplers to help prevent complications in the future. These devices are often used during laparoscopic urologic procedures.


METHODS
We retrospectively reviewed the experience with laparoscopic linear cutting staplers at two institutions routinely performing urologic laparoscopy and analyzed the difficulties with any staplers. Data from the Food and Drug Administration Center for Devices and Radiological Health were also examined to determine the prevalence and types of reported problems.


RESULTS
In performing approximately 460 laparoscopic cases, we encountered 5 problems (1%) with endovascular gastrointestinal anastomosis staplers. Fifty-five additional cases in 50 patients were documented in the Food and Drug Administration database. Of the 55 patients, 15 (27%) required open conversion to manage the problem, 8 (15%) received blood transfusions, and 2 (4%) died postoperatively. Twenty-two events occurred during 19 laparoscopic donor nephrectomies (35%) without associated graft dysfunction, damage, or loss. All phases of instrument use were subject to problems; however, abnormal firing of the stapler and improper staple formation were the most common and morbid aspects of device malfunction.


CONCLUSIONS
Despite the general reliability of linear cutting staplers, difficulties were encountered in every step of use. Most situations were successfully managed by prompt identification and appropriate intracorporeal maneuvers. Nevertheless, significant morbidity may occur, and conversion to an open operation should be considered. Many potential problems can be avoided by surgeon and staff education, and one should be aware of the alternative methods of tissue ligation currently available.
D004868:Equipment Failure; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects* / Q000379:methods; D008026:Ligation / Q000379:methods; D012189:Retrospective Studies; D013528:Surgical Staplers / Q000009:adverse effects*; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*