BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2890501 · Received December 21, 2012

    Report

    Report Number
    2890501
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NOVASURE DEVICE HAD VACUUM PROBLEM AND WOULD NOT ENABLE AND PERFORM ABLATION. A NEW DEVICE WAS OPENED AND WORKED WITHOUT ISSUE.THE PATIENT WAS NOT HURT AND FINISHED PROCEDURE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. NS2007 12G31R

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NONE KNOWN