BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    MDR report key: 2231612 · Received August 15, 2011

    Report

    Report Number
    1037905-2011-00530
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS RETURNED TO OUR APPROVED SUPPLIER FOR EVAL. BASED ON THEIR EVAL WE CAN PROVIDE THE FOLLOWING; THE DEVICE WAS CONFIRMED TO OPEN AND CLOSE PROPERLY. UNDER MAGNIFICATION THE FORCEPS CUPS WERE OBSERVED TO MATE PROPERLY AND WITHIN SPECIFICATION. THERE WERE NO ABNORMALITIES NOTED AND THE DEVICE OPERATED AS INTENDED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS RECEIVED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST WAS THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED LARGE FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG 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. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE PHYSICIAN SELECTED A COOK CAPTURA SERRATED LARGE FORCEPS WITH SPIKE. THE FORCEPS WERE ADVANCED THROUGH THE ENDOSCOPE. UPON EXITING THE END OF THE ENDOSCOPE, THE USER NOTICED THE SERRATED TEETH DID NOT LINE UP PROPERLY. BIOPSIES IN THE TRANSVERSE COLON WERE ATTEMPTED, BUT DUE TO THE MISALIGNMENT, THE BIOPSIES WERE REPORTED TO BE UNACCEPTABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA SERRATED LARGE FORCEP-SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC W2976902

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) OLYMPUS ENDOSCOPE