BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 2993024 · Received March 1, 2013

    Report

    Report Number
    3006524618-2013-00090
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K032504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY USING THE COBLATOR II CONTROLLER, WHEN THE FOOT PEDAL WAS PRESSED THE DEFAULT SETTING KEPT CHANGING TO A DIFFERENT SETTING. THE SURGEON CHOSE TO COMPLETE THE CASE WITH A COMPETITOR'S PRODUCT. THERE WAS NO SIGNIFICANT DELAY OR PATIENT COMPLICATION REPORT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89928 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other