ENDO GRASP

Additional Manufacturer Narrative

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

THE WHITE COVER, WHICH IS NEAR THE JAWS, WAS BROKEN. THE DEVICE WAS NOT USED ON THE PATIENT.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE ROTICULATOR ENDO GRASP. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE CLEAR SHEATH PROXIMAL THE JAWS OF THE DEVICE IS PARTIALLY PEELED AWAY. THE DEVICE FUNCTIONS PROPERLY. 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 EVENT CAN OCCUR DURING EXCESSIVE MANIPULATION OF THE DEVICE WHILE RETRACTING CAUSING THE SHEATH TO GET CAUGHT ON THE BLACK SHAFT AND TEAR. 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

THE SURGEON FELT IT WAS NOT SAFE TO USE. IT WAS NOT ASSOCIATED WITH THE PATIENT.