CENTRA

Additional Manufacturer Narrative

THE CENTRA DISPOSABLE BIOPSY FORCEPS SUBJECT OF THE EVENT WERE DISCARDED BY USER FACILITY PERSONNEL AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. WITHOUT THE RETURN AND EVALUATION OF THE DEVICES, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. USER FACILITY PERSONNEL STATED THAT NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE CENTRA DISPOSABLE BIOPSY FORCEPS DURING PRE-PROCEDURE CHECKS. THE INSTRUCTIONS FOR USE 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 OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE CENTRA DISPOSABLE BIOPSY FORCEPS HOWEVER, THE USER FACILITY DECLINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE SUBJECT LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED DURING PATIENT PROCEDURES WITH THE USE OF A CENTRA DISPOSABLE BIOPSY FORCEPS, THE USER NOTED BLEEDING AT THE BIOPSY SITE, TEARING OF THE TISSUE, AND DIFFICULTY REMOVING THE TISSUE FROM THE DEVICE TEETH. THE PATIENT PROCEDURES WERE COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.