ENDOUROLOGY & LAPAROSCOPY

Laparoscopic linear cutting stapler failure
Deng DY, Meng MV, Nguyen HT, Bellman GC, Stoller ML
From the Department of Urology, University of California, San Francisco, School of Medicine, San Francisco, California, USA and the Department of Urology, Kaiser Permanente Medical Center, Los Angeles, California, USA
Urology 2002; 60:415-9

• Objectives: 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.
  
  
• Editorial Comment
  This article follows a similar one by Chan and associates (1), from Johns Hopkins, published in 2000, which summarized 10 cases of linear cutting stapler failure in a series of 565 cases. An interesting feature of the current article is the use of the FDA database to identify an additional 55 cases of staplers malfunction. All the details of this additional group of events are not available, but it is likely, as in the personal series reported in this article, and in the one of Chan and associates (1), that operator error was responsible for many of the stapler malfunctions. Applying the stapler over a clip appears to be the most common mechanism of failure. The second most common problem appears to be bleeding from a staple line, without any apparent technical error. Although I have not reviewed the stapler malfunctions in my personal series (620 laparoscopic cases, including 443 nephrectomies) as carefully as have these authors, I certainly do not think that I’ve seen 6 to 10 stapler malfunctions (1 to 1.7%), the range noted in these 2 articles. Although I am not able to directly compare my technique to that of Deng and associates and Chan and associates (1), we generally use staplers only on a well dissected renal vein (very rarely on arteries), and we control branches into the vein to be stapled with bipolar electrocautery rather than clips (2). This obviates the most common mechanism of failure, that being the application of the stapler over a clip. The only significant stapler failure that I can recall in my series has been when, in an attempt to address a “sticky” renal hilum, we used the stapler over a mass of tissue that, in retrospect, was too thick to be handled by a stapler. This was an error in judgment; again, user error is the most common cause of stapler failure. The importance of this article and the previous one (1) is to highlight the importance of avoiding these technical errors, and to remind the laparoscopic surgeon that on very rare occasions there can be primary device failure. All laparoscopic surgeons using linear cutting staplers should have a plan worked out in advance in the event of stapler malfunction.

References
1. Chan D, Bishoff JT, Ratner L, Kavoussi LR, Jarret TW: Endovascular gastrointestinal stapler device malfunction during laparoscopic nephrectomy: early recognition and management. J Urol. 2000; 164:319-21.
2. Schuster TG, Wolf JS Jr.: Use of bipolar electrocautery during laparoscopic donor nephrectomy. J Urol. 2001; 165:1968-70.

Dr. J. Stuart Wolf Jr.
Associate Professor of Urology
University of Michigan
Ann Arbor, Michigan, USA