BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 5003330 · Received August 14, 2015

    Report

    Report Number
    0001811755-2015-02927
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CONTRACT MANUFACTURER WAS NOT ABLE TO CONFIRM THE REPORTED EVENT. SEVERAL COMPONENTS WERE REPLACED AS PREVENTIVE MAINTENANCE AND THE SOFTWARE WAS UPGRADED, THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY MULTIGEN HAD A GROUNDING PAD READ ERROR. AS A RESULT OF THE EVENT THE CASE WAS DELAYED ONE HOUR, THE PATIENT HAD ALREADY BEEN PREPPED. NO ADDITIONAL ANESTHESIA WAS NEEDED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY MULTIGEN HAD A GROUNDING PAD READ ERROR. AS A RESULT OF THE EVENT THE CASE WAS DELAYED ONE HOUR, THE PATIENT HAD ALREADY BEEN PREPPED. NO ADDITIONAL ANESTHESIA WAS NEEDED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540033 MULTIGEN RADIOFREQUENCY GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1