CAPTURA BIOPSY FORCEPS WITHOUT SPIKE

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PHOTO PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON STATEMENTS AND PHOTO DESCRIBING THE EVENT. THE PHOTO SHOWS THE FORCEPS CUPS STUCK IN AN OPEN POSITION AND THE DEVICE IS CUT JUST SLIGHTLY BELOW THE HANDLE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PHOTO PROVIDED CONFIRMED THE REPORT. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE PRODUCT INSPECTION: "BEGINNING AT THE HANDLE AND MOVING TOWARD THE CUPS, UNCOIL THE FORCEPS MAKING SURE NOT TO STRETCH THE CABLE. OPEN AND CLOSE THE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION. NOTE: EXERCISING THE HANDLE WHILE THE FORCEPS IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE FORCEPS." PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS WITHOUT SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE, IN WHICH A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE, WAS USED. IT WAS REPORTED THAT THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE HAD TO BE BROKEN IN ORDER TO REMOVE IT. IT WAS NOT POSSIBLE TO TAKE A BIOPSY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.