BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1053035 · Received May 15, 2008

    Report

    Report Number
    1053035
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 15, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS. A HOLOGIC COMPANY
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RED DIAL HANDPIECE WOULD NOT DIAL BACK TO CENTER ARROW AFTER CAVITY ASSESSMENT. PER MANUFACTURER REPRESENTATIVE, THE HANDPIECE WAS MALFUNCTIONING AND IT WAS REMOVED. A NEW DEVICE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE CATHETER, ABLATION, ENDOMETRIAL MNB CYTYC SURGICAL PRODUCTS. A HOLOGIC COMPANY NS2000 07M17HA

    Patients

    Seq Age Sex Outcome Treatment
    1 *