BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED JUMBO FORCEPS NO SPIKE

    MDR report key: 2181568 · Received July 6, 2011

    Report

    Report Number
    1037905-2011-00466
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. UNUSED PRODUCT WAS RETURNED TO COOK ON (B)(4) 2011. THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO THE APPROVED FORCEPS SUPPLIER FOR EVAL. A F/U MDR WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIVING THE RESULTS OF THE SUPPLIER EVAL. 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. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. THE EVAL OF THE UNUSED PRODUCT IS NOT YET COMPLETE. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HEMORRHAGE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. PRIOR TO DISTRIBUTION, ALL CAPTURA SERRATED JUMBO FORCEPS NO SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. 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 RECTAL BIOPSY, THE PHYSICIAN USED A COOK CAPTURA SERRATED JUMBO FORCEPS NO SPIKE. THE PHYSICIAN INDICATED SATISFACTION WITH THE BIOPSY SAMPLE SIZES. HOWEVER, WHEN TAKING A LARGE NUMBER OF SAMPLES (IE EIGHT) FROM A SMALL AREA, WHAT IS REPORTED TO BE AN AMOUNT OF BLEEDING THAT IS NOT FELT TO BE QUITE SAFE IS OBSERVED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA SERRATED JUMBO FORCEPS NO SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL WILSON-COOK MEDICAL INC W2963731

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)