ENDO DISSECT

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE PLASTIC CABLE SHEATH HAD SHEARING DAMAGE. A FUNCTIONAL EVALUATION FOUND THAT JAW ROTATION WORKED WITHOUT DIFFICULTY. JAW OPENED AND CLOSED WITHOUT DIFFICULTY, BUT ARTICULATION WAS DIFFICULT DUE TO THE DAMAGE TO THE DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHERE AN EXCESSIVE FORCE OR LEVERAGE IS APPLIED TO THE DEVICE WHILE RETRACTING THE CLEVIS ASSEMBLY AND THE CLEVIS BOOT IS SUBSEQUENTLY DAMAGED. THIS SUBSEQUENT DAMAGE MAY RESULT IN IMPROPER RETRACTION AND DEPLOYMENT OF THE JAWS DURING ARTICULATION AND MAY CAUSE SHEARING OF THE PLASTIC CABLE SHEATH. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS FOUND TO BE DUE TO THE DEVICE NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PLASTIC COVER OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.