BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 2946360 · Received February 6, 2013

    Report

    Report Number
    0001811755-2013-00188
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXCEEDED MAXIMUM TEMPERATURE AND SHUTDOWN DURING A PROCEDURE. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER LOCAL SEDATION. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXCEEDED MAXIMUM TEMPERATURE AND SHUTDOWN DURING A PROCEDURE. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER LOCAL SEDATION. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50200 RF GEN OBSOLETE REPLACED BY 0406900000 GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1