ENDO DISSECT

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND FOUR PHOTOS WERE AVAILABLE FOR EVALUATION. FUNCTIONAL TESTING FOUND THAT THE INSTRUMENT WAS APPLIED TO TEST MEDIA. THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY HOWEVER THERE WAS A SLIGHT GAP DUE TO THE MISALIGNMENT. IT WAS REPORTED THAT THE TIP OF THE FOUR DEVICES WERE NOT FULLY CLOSED. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE OF THE MISALIGNED JAWS MAY OCCUR WHEN THE DEVICE IS EXPOSED TO A SIDE FORCE (LEVERAGE) THAT CONSEQUENTLY BREAKS ONE SIDE OF THE JAWS. ANOTHER POSSIBILITY IS WHEN THE DEVICE IS ACTIVATED WITH TOO MUCH FORCE TO THE JAWS AND IS USED IN A TWISTING MOTION RESULTING IN BREAKAGE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: ENDOSCOPIC PROCEDURES SHOULD BE PERFORMED ONLY BY PHYSICIANS HAVING ADEQUATE TRAINING AND FAMILIARITY WITH ENDOSCOPIC TECHNIQUES. 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 CHOLECYSTECTOMY, WHEN DISSECTING THE FREE OMENTUM, THE TIP OF THE FOUR DEVICES WERE NOT FULLY CLOSED. THE USER OPENED ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 176645, 176645 ENDO DISSECT 254 (LOT#P4D1214); 176645, 176645 ENDO DISSECT 254 (LOT#P4A0946); 176645, 176645 ENDO DISSECT 254 (LOT#P4A0946) 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.