BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1243283 · Received November 10, 2008

    Report

    Report Number
    1243283
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 10, 2008
    Manufacturer
    CYTEC SURGICAL SERVICES, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR AN ENDOMETRIAL ABLATION WITH NOVASURE. THE PROCEDURE WAS INITIATED AS PLANNED, BUT WHEN THE NOVASURE WAS ATTEMPTED, IT WOULD NOT PASS THROUGH THE CAVITY SEAL. THE NOVASURE REPRESENTATIVE WAS PRESENT AND ATTEMPTED TO ASSIST THE PHYSICIAN WITH TROUBLE SHOOTING PROCEDURES. TWO ADDITIONAL DEVICES WERE USED AND THEY, TOO, WOULD NOT PASS THROUGH THE CAVITY SEAL. AT THIS POINT, THE PHYSICIAN ABORTED THE PROCEDURE.====================== MANUFACTURER RESPONSE FOR ENDOMETRIAL ABLATION, NOVASURE======================THE NOVASURE COMPANY WAS CONTACTED, AND CUSTOMER SERVICE WAS GIVEN THE INFORMATION. THE COMPANY HAS AGREED TO SEND A NEW CONTROLLER WITH 3 NEW DEVICES WITHIN THE NEXT 3 DAYS. THE COMPANY ASKED US TO RETURN THE CONTROLLER AND DEVICES IN THE ORIGINAL PACKAGING AND THAT THEY WOULD UNDERGO A TECHNICAL ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ENDOMETRIAL ABLATION DEVICE MNB CYTEC SURGICAL SERVICES, INC. * 08D05HA (DEVICES X 3)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR