BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ULTRA 45

    MDR report key: 4202570 · Received September 18, 2014

    Report

    Report Number
    3006524618-2014-00286
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NASAL PROCEDURE USING A REFLEX ULTRA 45 WAND, THE WAND WOULD NOT ACTIVATE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE 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
    580881 REFLEX ULTRA 45 ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORP 1043627

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other