BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2132348 · Received June 13, 2011

    Report

    Report Number
    1811755-2011-02147
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE, THE GENERATOR DISPLAYED AN ERROR MESSAGE. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACK UP EQUIPMENT WAS NOT AVAILABLE. THE PATIENT HAD ALREADY BEEN GIVEN LOCAL ANESTHESIA WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. THE PROCEDURE WAS COMPLETED 3 DAYS LATER WITH ALTERNATE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF MULTIGEN GXD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK