ENDO DISSECT

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE CLEVIS FIXTURE WAS BROKEN ON BOTH SIDES OF THE DEVICE. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT ARTICULATE PROPERLY. DEVICE FANNED OUT PROPERLY AND WITHOUT DIFFICULTY. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR BECAUSE OF THE INSTRUMENT BEING FORCED BEYOND ITS INDICATED USE DUE TO APPLYING EXCESSIVE STRESS OVER THE CLEVIS. THE PLASTIC CLEVIS WAS BROKEN FROM THE PIN HOLE; WHICH IS CONSISTENT WITH THE USE OF EXCESSIVE FORCE DURING THE PROCEDURE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, A PIECE OF THE INSULATION AT THE DISTAL END OF THE INSTRUMENT FELL INTO THE PATIENT'S CAVITY, WHICH WAS RETRIEVED WITH A GRASPER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.