BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2132322 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02134
    Event Type
    Malfunction
    Date Received
    June 11, 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
    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

    IT WAS REPORTED THAT THE GENERATOR DID NOT REACH THE DESIRED TEMPERATURE DURING AN RF PROCEDURE. TROUBLE SHOOTING EFFORTS WERE UNSUCCESSFUL AND BACK UP EQUIPMENT WAS NOT AVAILABLE. THE PROCEDURE WAS CANCELLED AS A RESULT.

    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