ENDO CLIP III

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.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL SURGERY, THE HANDLE WAS SQUEEZED, BUT THE CLIPS DID NOT LOAD PROPERLY. ADDITIONALLY, THE CLIP DID NOT CLOSE PROPERLY DURING APPLICATION AND DROPPED INTO THE ABDOMINAL CAVITY SEVERAL TIMES. IT WAS NOTED THAT ALL CLIPS WERE RETRIEVED. A NEW CLIP APPLIER WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.