BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1980037 · Received January 31, 2011

    Report

    Report Number
    MW5019245
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 31, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOVASURE ABLATION HANDPIECE WOULD NOT ADVANCE WHEN PLACED IN PT. OUTCOME: PROCEDURE NOT PERFORMED. OPERATION: HYSTEROSCOPY, D&C, FAILED ATTEMPT AT NOVASURE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ABLATION THERMAL -X2- MNB HOLOGIC 10607RB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other