BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTA 1 STRAIGHT INSTRUMENT

    MDR report key: 4022982 · Received July 11, 2014

    Report

    Report Number
    3006524618-2014-00203
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING A MANTA 1 STRAIGHT INSTRUMENT, THE INSTRUMENT STOPPED FUNCTIONING PROPERLY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S 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
    408217 MANTA 1 STRAIGHT INSTRUMENT INSTRUMENTS GEI ARTHROCARE CORPORATION 0406

    Patients

    Seq Age Sex Outcome Treatment
    1 Other