BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CUTTING LOOP/THIN

    MDR report key: 16552523 · Received March 15, 2023

    Report

    Report Number
    MW5115776
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 14, 2023
    Manufacturer
    LAMIDEY NOURY MEDICAL
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIPOLAR ELECTRODE USED FOR BLADDER TUMOR RESECTIONS WAS PLUGGED IN AND DID NOT WORK. THE ELECTRODE WAS UNPLUGGED, AND THE MACHINE WAS TURNED OFF AND RESTARTED. ONCE THE MACHINE WAS TURNED BACK ON, THE ELECTRODE WAS REINSERTED AND STILL DID NOT WORK. A NEW ELECTRODE WAS OBTAINED AND WORKED TO COMPLETE THE CASE. THE NON WORKING ELECTRODE WAS DISPOSED OF AND IS NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548569 BIPOLAR CUTTING LOOP/THIN ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS LAMIDEY NOURY MEDICAL 2226-3

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other