CENTRA

Additional Manufacturer Narrative

THE CENTRA BIOPSY FORCEPS SUBJECT OF THE REPORTED EVENT WAS DISCARDED BY USER FACILITY PERSONNEL PRIOR TO BEING RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, A CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE FOR THE BIOPSY FORCEPS STATES, "THE WHOLE DEVICE SHOULD BE CHECKED WHETHER THERE IS ANY DAMAGE (I.E., BEND OF CONNECTION PART AND INFLEXIBLE OPENING AND CLOSING OF FORCEPS) BEFORE USING THIS PRODUCT. IF THE PROBLEM EXISTS, PLEASE DO NOT USE. DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. DO NOT INSERT THE INSTRUMENT INTO THE ENDOSCOPE WHILE THE CUPS ARE OPEN. OTHERWISE, PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE COULD OCCUR. IT COULD ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. BIOPSY MAY CAUSE BLEEDING. IF YOU TAKE A LARGE SAMPLE OR PRESS THE INSTRUMENT'S DISTAL END AGAINST TISSUE EXCESSIVELY, THE RISK OF BLEEDING WILL INCREASE. PERFORM BIOPSY ON MINIMUM NECESSARY SPOTS ONLY. POTENTIAL COMPLICATIONS: THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: MUCOSAL TEARING, SWELLING, BLEEDING, PERFORATION AND INFECTION." STERIS CONDUCTED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION TO THE CENTRA BIOPSY FORCEPS. A COMPLAINT REVIEW WAS CONDUCTED FOR THIS LOT OF PRODUCTS AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR BIOPSY FORCEPS WERE NOT CUTTING AS DESIRED CAUSING TISSUE TEARING AND SUBSEQUENT BLEEDING. MEDICAL TREATMENT WAS ADMINISTERED AND THE BLEEDING WAS CONTROLLED USING A HEMOCLIP.