BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1873044 · Received October 14, 2010

    Report

    Report Number
    1222780-2010-00151
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 OF THE DISPOSABLE NOVASURE DEVICE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. NEITHER THE DEVICE NOR RADIO FREQUENCY CONTROLLER IS BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYSTEM CAN NOT 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. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS A LOT AND SERIAL NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN MONTHS FOLLOWING AN UNEVENTFUL NOVASURE PROCEDURE (POSSIBLE DATE OF (B)(6) 2010), THE PATIENT PRESENTED WITH "HEMATOMETRA AND CERVICAL STENOSIS". 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 SERIAL NUMBER UNK| RADIO FREQUENCY CONTROLLER