BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 4192855 · Received October 16, 2014

    Report

    Report Number
    MW5038707
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    HOLOGIC INC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOLOGIC NOVASURE IMPEDANCE CONTROLLER ENDOMETRIAL ABLATION DEVICE PASSED CAVITY ASSESSMENT AND ABLATION WAS INITIATED. AFTER APPROX 5 SECONDS, THE DEVICE STOPPED. ALL THE INFO WAS STILL PRESENT ON THE DISPLAY SCREEN, BUT THE NOVASURE ITSELF WAS NO LONGER ABLATING. THE PROCEDURE WAS COMPLETED WITH A SUBSEQUENT "LIKE" DEVICE WITHOUT ISSUE. DIAGNOSIS OR REASON FOR USE: UTERINE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657197 NOVASURE UTERINE ABLATION DEVICE MNB HOLOGIC INC NS2000US 14F18RC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR