BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE ABLATION KIT

    MDR report key: 3922809 · Received June 19, 2014

    Report

    Report Number
    3922809
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    October 15, 2013
    Report Date
    June 19, 2014
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A NOVASURE ENDOMETRIAL ABLATION. ON INITIAL TEST, THE UNIT DID NOT PASS THE CAVITY TEST; PERFORMED SECOND TEST WITH PASSING RESULTS. NEXT FOUR SINGLE ACTIVATIONS OF 10 SECONDS, 10 SECONDS, 9 SECONDS AND 39 SECONDS PERFORMED CONSECUTIVELY WITH MACHINE TURNING OFF AFTER EACH ACTIVATION. NEAR THE END OF THE 39 SECOND ABLATION, SMOKE WAS NOTED TO BE COMING OUT OF THE VAGINAL AREA AND THE NOVASURE MACHINE AUTOMATICALLY SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359741 NOVASURE ABLATION KIT DEVICE, THERMAL ABLATION MNB HOLOGIC, INC. * 13C08RD

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NOT KNOWN.
    2 *