BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2230988 · Received July 19, 2011

    Report

    Report Number
    1811755-2011-02599
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE, THE DEVICE DID NOT REACH THE DESIRED TEMPERATURE. TROUBLESHOOTING EFFORTS ADDED 45 MINS TO THE CASE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH BACK UP 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