BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 3130215 · Received May 22, 2013

    Report

    Report Number
    3006524618-2013-00203
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING THE COBLATOR II CONTROLLER, THE UNIT ALARMED AND THE COBLATION SETTINGS BEGAN CHANGING WITHOUT PROMPTING. THE FACILITY OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227679 COBLATOR II OPERATOR, CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR