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 TRANSABDOMINAL PREPERITONEAL PROCEDURE, THE BLACK PLASTIC PIECE ON THE TIP OF THE DEVICE BROKE AND FELL INTO THE PATIENT¿S CAVITY. THE COMPONENT WAS NOT RETRIEVED.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE PART OF THE SHEATH OF THE DEVICE RESPONSIBLE FOR RESTRICTING JAW OPENING HAD RIPPED APART. DEVICE ROTATED ABNORMALLY. 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 WHEN THE JAWS OF THE INSTRUMENT IS FORCED BEYOND INDICATED USE OR WHEN THE SHEATH AREA NEAR THE JAW IS EXPOSED TO EXCESSIVE SHEARING FORCES. 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.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL PROCEDURE, THE BLACK PLASTIC PIECE AT THE TIP OF THE DEVICE BROKE OFF AND DID NOT FALL INTO THE PATIENT CAVITY. THE PATIENT STATUS IS UNKNOWN.