BEUDAMED
    FDA Adverse Event Summary report: N

    NOVASURE

    MDR report key: 3943326 · Received May 6, 2014

    Report

    Report Number
    3943326
    Date Received
    May 6, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 6, 2014
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN FOR NOVASURE ENDOMETRIAL ABLATION. THE ENDOMETRIAL ABLATION NOVASURE DEVICE WAS PLACED INTO THE ENDOMETRIAL CAVITY. IT WAS MEASURED AT 4.5CM CAVITY DEPTH AS WELL AS AT 2.5CM CAVITY WIDTH. THE CAVITY TEST WAS PERFORMED AND THE DEVICE WAS UNABLE TO PASS THE CAVITY TEST, POSSIBLY INDICATING A BREECH IN THE UTERINE WALL. UNSUCCESSFUL, DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED AND THE HYSTEROSCOPE WAS PLACED AGAIN. ON THE POSTERIOR FUNDAL WALL THERE APPEARED TO BE AN AREA WHERE IT MAY HAVE BEEN A PERFORATION OF THE UTERUS. IT WAS NOT BLEEDING AND HEMOSTASIS OCCURRED. THIS WAS FELT TO BE THE REASON THE ENDOMETRIAL NOVASURE DEVICE WAS UNABLE TO PASS CAVITY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271605 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. NS2000US 13G22RG

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR