BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ELECTRODE

    MDR report key: 2140660 · Received June 20, 2011

    Report

    Report Number
    2140660
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    KARL STORZ
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ARCING FROM DISPOSABLE ELECTRODE ATTACHED TO A RESECTOSCOPE WHICH WAS CONNECTED TO ESU ELECTROSURGICAL UNIT. A DIFFERENT ELECTRODE FROM GYRUS ACMI LOT #289166C WAS USED SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ELECTRODE DISPOSABLE ELECTRODE GEI KARL STORZ * 41939

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR