ENDO BABCOCK

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE PLASTIC TIP WAS CRACKED THROUGH THE RIVET POINT RESULTING IN THE GRASPERS DETACHING. 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 EVENT CAN OCCUR DURING ROUGH HANDLING OF THE DEVICE. 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.

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

ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC RECTAL RESECTION PROCEDURE. THE DEVICE BROKE INSIDE THE ABDOMEN BUT WAS REMOVED IN FULL. THE PART THAT BROKE WAS BETWEEN THE SHAFT AND THE JAW. NO PARTS CAME LOOSE FROM THE DEVICE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER DEVICE. THERE WAS NO PATIENT HARM.