According to the reporter, during a laparoscopic cholecystectomy, the three jaw was not bouncing back or opening it was remaining half closed, the surgeon could not get the vessel into the jaws as it was too far closed, tried trouble shooting but nothing would make it open.A new device was used to resolve the issue.There was no patient injury.
|
D10 concomitant product: 176630 - 176630 endoclip iii 5mm applier, lot# j4a4310y 176630 - 176630 endoclip iii 5mm applier, lot# j4a4310y medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|