BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1893650 · Received November 4, 2010

    Report

    Report Number
    1222780-2010-00162
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 KNOWN. THE DEVICE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN REPORTED VIA LETTER THAT 1 WEEK FOLLOWING A NOVASURE ENDOMETRIAL ABLATION (DATE UNK) "IN A SMALL UTERUS WHOSE BODY WAS 4CM IN LENGTH", A 1CM PERFORATION WAS FOUND IN THE FUNDUS "WITH EVIDENCE OF CAUTERIZATION EFFECT SURROUNDING THE PERFORATION. SMALL BOWEL WAS ALSO FOUND TO HAVE BEEN PERFORATED BY CAUTERIZATION EFFECT. ON PATHOLOGY, THE BODY OF THE UTERUS WAS FOUND TO HAVE THE CAUTERIZATION EFFECT TO ALMOST THE SEROSAL SURFACE." WE HAVE BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFO 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