According to the reporter, during laparoscopic cholecystectomy, on ligation of the duct and artery, the two clip appliers were fired from but the clips were crossed and malformed.Another clip applier was used to complete the case.There was no patient injury.
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D10 concomitant product: 176625, 176625 disp endoclip lge, (lot #j3m2664ny) 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.
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