ENDO CLIP II

Description of Event or Problem

It was reported that during a laparoscopic cholecystectomy for acute cholecystitis, while clipping the hepatic artery and on the second firing, a clip malformed and tore a hole in the hepatic artery with associated bleeding. Unanticipated tissue loss and tissue damage were reported, and the tissue damage with a permanent injury outcome. A new clip applier was opened, the hepatic artery was clipped, and bleeding was controlled. Medical or surgical intervention was required to prevent permanent impairment of function. The event was reported to have extended hospitalization, and the patient was still hospitalized with the duration undetermined.

Additional Manufacturer Narrative

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. Medtronic will submit a supplemental report if additional relevant information becomes known.