Endo Clip III

Description of Event or Problem

It was reported that during an emergency laparoscopic appendectomy, the clip applier passed smoothly through the port for use and clips were applied without any obvious issues. However, when the surgeon attempted to remove the clip applier back through the port, it became stuck. The surgeon used the laparoscope to examine the clip applier and observed a piece of metal sticking through the shaft of the applier. To remove the clip applier safely, the surgeon removed the port itself. There was no patient injury.

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. 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.