BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1941789 · Received December 22, 2010

    Report

    Report Number
    1222780-2010-00205
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 OF THE DISPOSABLE NOVASURE DEVICE IS NOT KNOWN. NEITHER THE DEVICE NOR RADIO FREQUENCY CONTROLLER IS BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYS CANNOT BE COMPLETED. LOT AND SERIAL NUMBERS NOT PROVIDED BY COMPLAINANT; THEREFORE, THE MANUFACTURE DATE OF THE DISPOSABLE DEVICE AND RADIO FREQUENCY CONTROLLER IS NOT KNOWN. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYS. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE COMPLETION OF AN UNEVENTFUL NOVASURE ABLATION PROCEDURE (DATE UNK), THE PT EXPERIENCED ABDOMINAL PAIN AND HAD A HYSTERECTOMY (REASON AND DATE UNK). WE HAVE BEEN UNABLE TO OBTAIN 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