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.
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.
Authors: Moayid Fallatah; Abdullah W Aldughiman; Abdulrahman S Binjawhar; Bader A Melaibary; Hossam S El-Tholoth; Abdullah S Al-Gadheeb; Ahmad Y Alzahrani; Tarek M Zahrani; Hamad S Alakrash Journal: Urol Ann Date: 2022-02-15
Authors: Stephen S Johnston; Barbara H Johnson; Divya Chakke; Sanjoy Roy; Philippe Grange; Esther Pollack Journal: Med Devices (Auckl) Date: 2022-09-02