ENDO CLIP II

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

IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATECTOMY, THE CLIP APPLIER WAS USED FOR CLIPPING VESSELS AND, UPON INITIAL LOAD, THE DEVICE WAS DIFFICULT TO SQUEEZE AND A CRUNCH SOUND WAS HEARD. WHEN THE DEVICE WAS HANDED TO THE SURGEON, IT WOULD SOMETIMES LOAD AND SOMETIMES NOT LOAD, IT SOMETIMES PUSHED A CLIP OFF THE JAWS, AND IT WOULD NOT CLIP AT ALL. AT THE TIME THE ISSUE OCCURRED, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE, AND THE DEVICE JAWS DID NOT LOCK ONTO TISSUE. ANOTHER 10 MM CLIP APPLIER WAS OPENED AND WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.