BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTYC NOVASURE

    MDR report key: 1052686 · Received May 13, 2008

    Report

    Report Number
    1052686
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 9, 2008
    Manufacturer
    CYTYC SURGICAL SERVICES, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT TO UNDERGO NOVASURE ABLATION DUE TO MENOMETRORRHAGIA. PER OPERATIVE REPORT, THE CERVIX WAS GRASPED WITH A SINGLE-TOOTH TENACULUM. THE CERVIX WAS THEN DILATED WITH HEGAR DILATOR TO A #7. THE UTERUS SOUNDED TO 8.5 CM. THE ENDOCERVICAL CANAL WAS 2 CM. THE NOVASURE DEVICE WAS THEN INSERTED TO THE FUNDUS. THE SURGEON WAS HAVING A DIFFICULT TIME OPENING UP THE NOVASURE DEVICE AND LOCKING IT IN POSITION. THE NOVASURE WAS THEN AGAIN TESTED OUTSIDE THE BODY AND IT APPEARS TO BE WORKING. HOWEVER, ONCE INSERTED TO THE FUNDUS, THE SURGEON WAS NOT ABLE TO OPEN UP THE DEVICE EASILY. IT DID OPEN EVENTUALLY, BUT THE CAVITY WIDTH WAS NOT STABLE, RANGING FROM 3.5 CM TO 4.3 CM. AT THIS POINT, A SMALL PLASTIC PIECE FROM THE BACK OF THE NOVASURE DEVICE HAD BROKEN OUT OUTSIDE OF THE UTERUS. THE NOVASURE WAS THEN RETRACTED AND REMOVED. A HYDROTHERMAL ABLATION WAS THEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTYC NOVASURE CATHETER, ABLATION, ENDOMETRIAL MNB CYTYC SURGICAL SERVICES, INC. P/N: 615203 REV.A 07H21HC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR