BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1013345 · Received March 13, 2008

    Report

    Report Number
    1222780-2008-00020
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. THERE WERE NO REWORKS OR OBSERVATIONS NOTED AT TIME OF MFR AND IT WAS RELEASED BY QA ON 12/19/05. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. THE LOT NUMBER FOR THE DISPOSABLE DEVICE WAS NOT PROVIDED; THEREFORE, AN INVESTIGATION OR REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS NOT ABLE TO BE PERFORMED. NEITHER THE DISPOSABLE DEVICE NOR THE RADIO FREQUENCY CONTROLLER INVOLVED IN THIS EVENT. WERE RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED MULTIPLE UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS DURING A NOVASURE PROCEDURE. THE PROCEDURE WAS ABORTED AND PERFORATION WAS CONFIRMED ON HYSTEROSCOPY. THE PHYSICIAN REPORTED IN 2008 THAT NO TREATMENT WAS NEEDED FOR THE PERFORATION, AND THE PT IS CURRENTLY "OK" AND NOT EXPECTED BACK IN CLINIC UNTIL LATER THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other