BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1689193 · Received May 11, 2010

    Report

    Report Number
    1222780-2010-00068
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 11, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE EXPIRATION DATE IS NOT KNOW. SERIAL NUMBER OF THE RFC NOT PROVIDED BY THE COMPLAINANT. NEITHER THE DISPOSABLE DEVICE NOR RADIO FREQUENCY CONTROLLER IS BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYSTEM CANNOT BE COMPLETED. LOT AND SERIAL NUMBERS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MANUFACTURE DATE OF THE DISPOSABLE DEVICE AND RADIO FREQUENCY CONTROLLER IS NOT KNOWN. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION PROCEDURE, THE PHYSICIAN PERFORMED A LAPAROSCOPY AND NOTED "BLANCHING" ON THE FUNDUS. THE PT RECEIVED NO ADVERSE EFFECTS AS A RESULT OF THIS. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK