BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGON T2 WITH INTEGRATED CABLE

    MDR report key: 3994353 · Received July 23, 2014

    Report

    Report Number
    3006524618-2014-00218
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING A PARAGON T2 ICW WAND, THE CONTROLLER WOULD NOT RECOGNIZE THE WAND. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431045 PARAGON T2 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION E528320-G

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR