BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF MULTIGEN

    MDR report key: 2102543 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01811
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE AT C4-C6, THE PRODUCT DID NOT REACH THE DESIRED TEMPERATURE. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACK UP WAS NOT AVAILABLE. THE PT HAD ALREADY BEEN GIVEN LOCAL ANESTHESIA WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE REPORTED 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