BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3502150 · Received November 27, 2013

    Report

    Report Number
    MW5033238
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    November 22, 2013
    Report Date
    November 26, 2013
    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

    THE FIRST HOLOGIC, INC. NOVASURE DEVICE THAT WAS OPENED DID NOT WORK AT ALL. WHEN IT WAS ACTIVATED, THE MACHINE ALARMED AND IT WOULD NOT WORK. ANOTHER "LIKE" DEVICE WAS OPENED AND IT WORKED WITHOUT ANY PROBLEMS. REASON FOR USE: D&C, HYSTEROSCOPY, ENDOMETRIAL ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618036 NOVASURE ENDOMETRIAL ABLATION SYSTEM MNB HOLOGIC, INC. NS2000US 13G22RG

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR