Analysis of Techniques to Secure the Renal Hilum During Laparoscopic Donor Nephrectomy: Review of the FDA Database

Objectives: To characterize the mechanisms of failure and patient outcomes during complications with the use of endoscopic stapling devices, nonlocking titanium clips, and locking polymer clips during laparoscopic donor nephrectomy. Methods: The Food and Drug Administration's medical device complication database, Manufacturer and User Facility Device Experience database (MAUDE), was evaluated for pure and hand-assisted laparoscopic donor nephrectomies from 1992 to 2007 with the broadest keywords possible. In an attempt to estimate the failure rates by device type, a "denominator of use" was calculated using Organ Procurement and Transplant Network data multiplied by previously published survey-determined usage rates. Results: In the 92 complications identified, 59 (64%), 21 (23%), and 12 (13%) failures of endoscopic staplers, titanium clips, and locking clips had occurred, respectively. The most common mechanisms of stapler failure were missing/malformed staple lines (51%) and failure to release (25%). The most common titanium clip failures resulted from scissoring or malformation (52%), jamming (19%), and dislodgement (14%). Clip dislodgement was most common with the locking clip, either postoperatively in 7 (58%) or intraoperatively in 3 (25%). Intraoperative conversions were required for 21 (36%), 1 (5%), and 2 (17%) for staplers, titanium clips, and locking clips, respectively. The estimated overall failure rate was 3.0% for staplers, 4.9% for titanium clips, and 1.7% for locking clips. Conclusions: The anticipation of potential device-specific failures during laparoscopic donor nephrectomy, coupled with knowledge of how to handle failure when it does occur, could improve procedure safety.