BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 4131565 · Received October 1, 2014

    Report

    Report Number
    0001811755-2014-03441
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRACT MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO AN INTERMITTENT INVERTER CABLE. BASED ON THE RISK DOCUMENTATION, A SHORT CIRCUIT IN THE INVERTER CABLE CAN CAUSE THE BACKLIGHT OF THE LCD (DISPLAY) TO NOT WORK. THE CONTRACT MANUFACTURER REPLACED THE INVERTER CABLE AND THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY GENERATOR WOULD NOT TURN ON DURING THE BEGINNING OF A CASE WHILE THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE PROCEDURE WAS STOPPED AND RESCHEDULED FOR LATER THAT DAY. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612986 RF GEN OBSOLETE REPLACED BY 0406900000 GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1