BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP, CUTTING, COOK

    MDR report key: 2210126 · Received July 29, 2011

    Report

    Report Number
    2210126
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    November 11, 2010
    Report Date
    May 24, 2011
    Manufacturer
    COOK MEDICAL
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALL FOUR LOOPS BROKE DURING UROLOGY SURGERY. ALL FOUR DEVICES HAD THE SAME LOT NUMBER AND SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOP, CUTTING, COOK RESECTOSCOPE ELETRODES FDC COOK MEDICAL G46199 U1940572
    2 LOOP, CUTTING RESECTOSCOPE ELECTRODES FDC COOK MEDICAL G46199 U1940572
    3 LOOP, CUTTING RESECTOSCOPE ELECTRODES FDC COOK MEDICAL G46199 U1940572
    4 LOOP, CUTTING RESECTOSCOPE ELETRODES FDC COOK MEDICAL G46199 U1940572

    Patients

    Seq Age Sex Outcome Treatment
    1 *