BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3231178 · Received July 5, 2013

    Report

    Report Number
    3231178
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 5, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE DEVICE. THE SURGEON COULD NOT CREATE A SEAL AT CERVIX. MANUFACTURER WAS CONTACTED AND TROUBLESHOOTING WAS PERFORMED WITH NO SUCCESS. A NEW DEVICE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307245 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 13A11RC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR