CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Description of Event or Problem

DURING AN ENDOSCOPIC PROCEDURE TO TAKE BIOPSY SAMPLES IN THE DUODENUM, THE PHYSICIAN USED 2 COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT ONCE THE FIRST DEVICE HAD PASSED THE CANAL OF THE ENDOSCOPE, IT COULD BE OPENED BUT THEN IT COULD NOT CLOSE. THE SECOND DEVICE COULD OPEN WELL, BUT WHEN THEY WANTED TO CLOSE, IT TOOK TIME AND THEY FELT A LOT OF RESISTANCE. BOTH PRODUCTS WERE USED IN THE SAME PROCEDURE. 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.

Additional Manufacturer Narrative

CONTINUED: E1 COUNTRY: SPAIN. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: 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 PRO¿ BIOPSY FORCEPS WITH 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

THIS FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL EMDR. SEE SECTION H11 MORE FURTHER DETAILS.

Additional Manufacturer Narrative

THIS MDR FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. IT WAS ORIGINALLY REPORTED THAT THE CUPS WOULD NOT CLOSE, WHICH IS AN FDA REPORTABLE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION ON 14FEB2025 AND DETERMINED THAT THE CUPS ARE MISALIGNED. CUP MISALIGNMENT IS NOT AN FDA REPORTABLE EVENT. THEREFORE, THIS EVENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.