BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II SURGERY SYSTEM

    MDR report key: 2822966 · Received October 23, 2012

    Report

    Report Number
    3006524618-2012-00843
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WAND DID NOT FUNCTION UPON BEING PLUGGED INTO THE CONTROLLER. THE PROCEDURE WAS COMPLETED USING REVERT TO THE TRADITIONAL CAUTERY METHODS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II SURGERY SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other