ENDO CLIP II

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: 176657, 176657 ENDOCLIP II ML 10 APPLI (LOT#:J5M2444NY). 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 INTRA-OPERATIVELY OF A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE IN THE CYSTIC ARTERY, CLIPS FROM TWO CLIP APPLIER FELL INTO THE CAVITY. THE JAWS CROSSED AND COULD NOT BE CLOSED PROPERLY. THERE WAS BLOOD LOSS OF 500CC OR MORE. THE LAPAROSCOPIC PROCEDURE WAS CONVERTED TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 120 MINUTES.