FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION, THE DRIVE WIRE WITH A U-JOINT CONNECTOR WAS FOUND TO BE BENT OUT OF ITS POSITION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING SHIPPED TO THE ACCOUNT. AS THE DEVICE WAS USED DURING THE PROCEDURE, NO DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD BE DETERMINED. PER THE INSTRUCTIONS FOR USE, THE PRODUCT IS TO BE INSPECTED FOR SIGNS OF DAMAGE OR STERILITY COMPROMISE PRIOR TO USE. AS THE DEVICE WAS INSERTED INTO THE COLONOSCOPE, IT IS ASSUMED THERE WAS NO OBSERVED DAMAGE OR BENT WIRING PRIOR TO INSERTION. AS NOTED IN THE INSTRUCTIONS FOR USE, IF EXCESSIVE PRESSURE WAS APPLIED DURING ADVANCEMENT INTO THE TISSUE OR DURING HANDLE MANIPULATION, THIS COULD ¿CAUSE JAW DAMAGE¿. A BENT OR CONSTRICTED DRIVE WIRE ON THE DEVICE MAY HAVE BEEN CAUSED BY FORCEFUL INSERTION OF THE INSTRUMENT AND/OR CAUSED BY OVER-ANGULATION OF THE ENDOSCOPE DURING THE PROCEDURE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS NOT REVIEWED AS NO LOT NUMBER WAS GIVEN.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE BROKE MID-PROCEDURE OF A GI CASE WHILE IN THE PATIENT. NO PATIENT HARM OR CONSEQUENCES RESULTED IN THIS. ADDITIONAL DETAILS WERE GIVEN AS FOLLOWS: THE JAW WAS RETRIEVED AND THERE WAS NO DAMAGE TO THE PATIENT. THE WIRE WAS STICKING OUT OF THE JAW.