V. MUELLER

Additional Manufacturer Narrative

STERIS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND TO HAVE THE JACOBSON MOSQUITO FORCEPS SUBJECT OF THE REPORTED EVENT RETURNED FOR EVALUATION HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE LOT NUMBER FOR THE FORCEPS SUBJECT OF THE EVENT WAS NOT PROVIDED IN MEDWATCH # (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR."

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) "AT THE END OF A PEDIATRIC HERNIA REPAIR, THE STAFF IDENTIFIED A FORCEPS INSTRUMENT HAD A BROKEN TIP. THE SURGEON WAS QUESTIONED AND THEY WERE CERTAIN THAT THEY DIDN'T USE THIS SPECIFIC FORCEPS FOR THE PROCEDURE AND THAT IT MUST HAVE BEEN THAT WAY BEFORE THEY STARTED. TO BE SAFE, LEADERSHIP ASKED THE TEAM TO DO AN X-RAY IN WHICH IT CAME BACK WITH NOTHING LEFT BEHIND."