BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE IMPEDANCE CONTROLLED ENDROMETRIAL ABLATION

    MDR report key: 1091223 · Received July 31, 2008

    Report

    Report Number
    MW5007870
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 31, 2008
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ENDOMETRIAL ABLATION IN OR USING THE NOVASURE PRODUCT. AT THE CONCLUSION OF THE PROCEDURE, THE ELECTRODE ARRAY WOULD NOT RETRACT INTO THE SHEATH. THE PHYSICIAN WAS ABLE TO MANIPULATE THE EQUIPMENT AND REMOVE IT FROM THE PATIENT'S UTERUS WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED ENDROMETRIAL ABLATION NONE MNB HOLOGIC 08A07H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR