title: Analysis of techniques to secure the renal hilum during laparoscopic donor nephrectomy: review of the FDA database.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Urology, Loma Linda University Medical Center, Loma Linda, California 92354, USA.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Hsi
authors.forename: Okechukwu N
authors.initials: ON
authors.lastname: Ojogho
authors.forename: D Duane
authors.initials: DD
authors.lastname: Baldwin
mesh_terms: D016208:Databases, Factual; D004868:Equipment Failure; D006801:Humans; D007668:Kidney / Q000601:surgery*; D010535:Laparoscopy; D009392:Nephrectomy / Q000295:instrumentation* / Q000379:methods*; D012189:Retrospective Studies; D014019:Tissue Donors; D014481:United States; D014486:United States Food and Drug Administration