BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 3983069 · Received August 6, 2014

    Report

    Report Number
    0001811755-2014-02806
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE RF GENERATOR DISPLAYED AN HIGH IMPENDENCE ERROR MESSAGE, WHICH RESULTED IN THE CANCELLATION OF THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED LOCAL ANESTHESIA PRIOR TO THE PROCEDURE BEING CANCELED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE RF GENERATOR DISPLAYED AN HIGH IMPENDENCE ERROR MESSAGE, WHICH RESULTED IN THE CANCELLATION OF THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED LOCAL ANESTHESIA PRIOR TO THE PROCEDURE BEING CANCELED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461587 RF GEN OBSOLETE REPLACED BY 0406900000 GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1