BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100MM MONOPOLAR NITINOL ELECTRODE

    MDR report key: 3120694 · Received May 20, 2013

    Report

    Report Number
    0001811755-2013-01139
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRODES ON THE DEVICE WERE NOT BEING DETECTED BY THE GENERATOR. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR A LATER DATE. IT IS UNKNOWN AT THIS TIME IF ANESTHETIC WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221455 100MM MONOPOLAR NITINOL ELECTRODE GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

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