BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIY

    MDR report key: 2088194 · Received May 9, 2011

    Report

    Report Number
    MW5020543
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 9, 2011
    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

    HYSTEROSCOPE WAS REMOVED AND THE NOVASURE ENDOMETRIAL ABLATION DEVICE WAS INSERTED AND DEPLOYED. SEATING MANEUVERS WERE DONE. DEPTH OF 6.5CM AND WIDTH OF 4.6CM WERE NOTED. UTERINE ASSESSMENT PROCEDURE FAILED AND IT WAS REPEATED SEVERAL TIMES. HYSTEROSCOPY REPEATED TO ENSURE INTEGRITY OF THE UTERINE CAVITY. SECOND NOVASURE DEVICE WAS INSERTED, PROCEDURE REPEATED AND THE UTERINE ASSESSMENT FAILED. DECISION WAS MADE TO ABORT THE PROCEDURE. ENDOMETRIAL CAVITY WAS THOROUGHLY CURETTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OPERATING ROOM IN GOOD CONDITION. NOVASURE MACHINE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIY ENDOMETRIAL ABLATION DEVICE MNB HOLOGIC, INC. NS 2000 TIMES 2 11A25RB TIMES 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other