title: Mechanisms of hemostatic failure during laparoscopic nephrectomy: review of Food and Drug Administration database.
abstract: OBJECTIVE
  To compare the complications with endovascular stapling devices, nonlocking titanium clips, and nonabsorbable polymer ligating (Hem-o-lok) clips during laparoscopic nephrectomy.
  
  
  METHODS
  The Food and Drug Administration Manufacturer and User Facility Device Experience Database was retrospectively reviewed for reports dated from January 1992 to March 2006 using the key words "nephrectomy" and "kidney." All episodes of pure and hand-assisted laparoscopic nephrectomy were evaluated.
  
  
  RESULTS
  Of 2172 total nephrectomy or kidney-related reports, 352 reported failure using laparoscopic hemostatic devices to secure the renal vasculature, and 223 complications (63%) resulted during the use of endovascular stapling devices, 111 (33%) from nonlocking titanium clips and 18 (5%) from locking clips. The leading causes of failure reported in stapling devices were staple line malformation (47%) and locking up (29%). In titanium clips, jamming/feeding difficulties (27%) and trouble closing or "scissoring" clips (26%) were the most common. In locking clips, dislodgement (44%) was most frequently reported. Three, one, and three deaths were reported after the use of the stapling device, titanium clip, and locking clip device, respectively.
  
  
  CONCLUSIONS
  All three methods used to secure the renal hilum in laparoscopic nephrectomy can result in malfunction. Because the overall denominator of use is not known, it would be inappropriate to conclude that one device is safer than another. When they occurred, these device malfunctions were potentially serious. Knowledge of the possible mechanisms of failure seen with each device could allow surgeons to anticipate potential complications and, therefore, perform laparoscopic surgery more safely.
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: Daniel T
authors.initials: DT
authors.lastname: Saint-Elie
authors.forename: Grenith J
authors.initials: GJ
authors.lastname: Zimmerman
authors.forename: D Duane
authors.initials: DD
authors.lastname: Baldwin
mesh_terms: D006488:Hemostasis, Surgical / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008026:Ligation / Q000009:adverse effects / Q000295:instrumentation; D009392:Nephrectomy / Q000379:methods*; D012189:Retrospective Studies; D013528:Surgical Staplers / Q000009:adverse effects*; D017211:Treatment Failure; D014481:United States; D014486:United States Food and Drug Administration