ENDO CLIP III

Description of Event or Problem

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PHYSICIAN EXPERIENCED PROBLEMS WITH THE CLIPS NOT STAYING COMPLETELY CLOSED DESPITE SQUEEZING TIGHTLY AND THE NEXT CLIP NOT COMING FORWARD. THE HANDLE WAS REPORTEDLY ABLE TO BE SQUEEZED. IT WAS NOTED THAT THERE WAS TISSUE DAMAGE DUE TO HAVING TO REMOVE THE CLIP, AND THE INCISION WAS EXTENDED. TO RESOLVE THE ISSUE, A NEW CLIP APPLIER WAS OPENED, AND THE PROCEDURE CONTINUED.

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.