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.
|
According to the reporter, during laparoscopic cholecystectomy, the surgeon noticed that the clips got a little tangled, malformed and scissored.This means that the clips were not stuck but are very easy to remove.Another clip applier was used to complete the case.
|