BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS RF-S WHIRLWIND 90 DEGREE PROBE WITH INTEGRA

    MDR report key: 2950510 · Received February 5, 2013

    Report

    Report Number
    3006524618-2013-00052
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K090393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING THE DYONICS WHIRLWIND 90 PROBE, THE PROBE ALARMED. THE SURGEON CHOSE TO FINISH THE PROCEDURE WITH COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49066 DYONICS RF-S WHIRLWIND 90 DEGREE PROBE WITH INTEGRA ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other