BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 2990786 · Received March 5, 2013

    Report

    Report Number
    0001811755-2013-00449
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 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 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. THE DEVICE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING DURING A SURGICAL PROCEDURE. THE CASE HAD TO BE RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92847 RF GEN OBSOLETE REPLACED BY 0406900000 GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1