ETHICON

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PLASTIC PORTION OF THE REPROCESSED ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG (PURPLE) 12MM X 100MM, FRACTURED DURING INSUFFLATION. PER REPORT, THE BROKEN PIECE REACHED THE SURGICAL SITE AND WAS SUCCESSFULLY REMOVED FROM THE SURGICAL SITE THROUGH AN UNIDENTIFIED 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 DURING INSUFFLATION, THE PLASTIC PORTION OF THE REPROCESSED ENDOPATH® XCEL¿ BLUNT TIP TROCAR FRACTURED AND REACHED THE SURGICAL SITE. THIS WAS SUCCESSFULLY RETRIEVED THROUGH AN UNIDENTIFIED METHOD.