ENDO DISSECT

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 A PROCEDURE THE WHITE ARTICULATING LEVER WAS BROKEN.

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 GROOVED ARTICULATION COLLAR HAD BEEN DISENGAGED FROM THE BODY OF THE DEVICE. PMV PERFORMED FUNCTIONAL TESTING AND THE JAW WAS ARTICULATED MANUALLY BY HOLDING THE ARTICULATION COLLAR IN ORIGINAL PLACE ON DEVICE AND ROTATED, JAW ARTICULATED WITHOUT DIFFICULTY. JAW ROTATION WORKED. RELEASE LEVER AND JAW TOGGLE FUNCTIONED PROPERLY. DEVICE JAWS OPENED AND CLOSED FULLY. 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 BROKEN ARTICULATION COLLAR OCCURS WHEN THE ARTICULATION COLLAR IS ROTATED BEYOND THE POINT OF FULL JAW RETRACTION USING A FORCE LARGE ENOUGH TO CAUSE RUPTURE OF THE ARTICULATION COLLAR ATTACHMENT. 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. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.