CENTRA

Additional Manufacturer Narrative

THE CENTRA BIOPSY FORCEPS SUBJECT OF THE REPORTED EVENT ARE NOT AVAILABLE FOR EVALUATION. WITHOUT THE RETURN AND EVALUATION OF THE CENTRA DISPOSABLE BIOPSY FORCEPS, A CAUSE OF THE REPORTED EVENTS COULD NOT BE DETERMINED. THE LOT NUMBER FOR THE CENTRA BIOPSY FORCEPS WAS NOT PROVIDED BY USER FACILITY PERSONNEL. WITHOUT THE LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. STERIS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND TO HAVE THE CENTRA BIOPSY FORCEPS SUBJECT OF THE REPORTED EVENT RETURNED FOR EVALUATION HOWEVER, THE USER FACILITY HAS NOT RESPONDED. 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 THAT DURING A PATIENT PROCEDURE, THE CENTRA BIOPSY FORCEPS WERE "PULLING THE TISSUE" RESULTING IN BLEEDING. NO REPORT OF PROCEDURE DELAY.