ENDO DISSECT

Additional Manufacturer Narrative

CORRECTION: EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. PMV FOUND SHEARING DAMAGE OF THE PLASTIC CABLE SHEATH. ENGINEERING CONFIRMED DAMAGE AND FOUND TO BE CONSISTENT WITH A MISHANDLING OF 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. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. 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 WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. 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: OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE DEVICES WERE BEING USED FOR THE DISSECTION. BOTH DEVICES HAD A BURN AT THE END OF THE ROTICULATOR. BOTH DEVICES WERE ABLE TO GRASP PROPERLY AND THE HANDLES DID NOT BIND. THE PATIENT'S MEDICAL HISTORY IS SMOKING. THERE WAS NO PATIENT INJURY.