ETHICON

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PLASTIC SLEEVE OF THE REPROCESSED ETHICON'S ENDOPATH XCEL BLUNT TIP TROCAR, W/SMOOTH SLEEVE AND ADJUSTABLE PLUG, (PURPLE) 12MM X 100MM, BROKE OFF INSIDE THE PATIENT DURING AN UNIDENTIFIED CASE. PER REPORT, THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT THROUGH AN UNSPECIFIED METHOD. THERE WAS NO REPORT OF A SERIOUS INJURY, AN ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THIS INCIDENT. DUE TO THE REPORTED EVENT AND REQUIRED MEDICAL INTERVENTION TO RETRIEVE THE BROKEN PIECE FROM THE SURGICAL SITE, THIS MEDWATCH IS BEING FILED. THE DEVICE WAS RETURNED FOR EVALUATION AND THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED AND INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE PLASTIC SLEEVE OF THE REPROCESSED ETHICON TROCAR BROKE OFF INSIDE THE PATIENT DURING AN UNIDENTIFIED PROCEDURE.