BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1275583 · Received December 23, 2008

    Report

    Report Number
    1275583
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    December 11, 2008
    Report Date
    December 23, 2008
    Manufacturer
    CYTYC SURGICAL SERVICES, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OR STAFF REPORT THAT THE NOVASURE ENDOMETRIAL ABLATION DEVICE SHUT OFF ON ITS OWN IN 30 SECONDS AND ONLY ABLATED HALF OF THE UTERUS. THE DEVICE DID NOT FAN OUT IN THE UTERUS AND THE ABLATION WAS INCOMPLETE. AS A RESULT, THE PROCEDURE WAS DELAYED. THE MD WAS UNABLE TO COMPLETE THE ABLATION.====================== MANUFACTURER RESPONSE FOR ENDOMETRIAL ABLATION KIT, NOVASURE CYTYC SURGICAL PRODUCTS======================OR STAFF NOTIFIED THE REP ON THE DAY OF OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE THERMAL ABLATION, ENDOMETRIAL MNB CYTYC SURGICAL SERVICES, INC. * 08E23HA

    Patients

    Seq Age Sex Outcome Treatment
    1 *