BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2803061 · Received October 17, 2012

    Report

    Report Number
    1222780-2012-00225
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN DID A LAPAROSCOPY AND NOTED "BLOOD COMING FROM THE PATIENT'S URETER AND SLIGHT BLANCHING OF THE UTERUS". NO TREATMENT WAS NOTED FOR THIS AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2012, IT WAS REPORTED THE PATIENT IS DOING FINE.

    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