BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3212735 · Received June 28, 2013

    Report

    Report Number
    1222780-2013-00123
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 30, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. THERE WERE NO REWORDS OR OBSERVATIONS NOTED AT TIME OF MANUFACTURE. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2013. POST HYSTEROSCOPY WAS PERFORMED AND REVEALED "GOOD ABLATION". ON (B)(6) 2013 THE PATIENT PRESENTED TO THE HOSPITAL WITH "BAD PERIOD PAINS AND PAIN WITH VIBRATIONS (WALKING, SITTING, ETC.)". THE PATIENT WAS "PRESCRIBED ANTIBIOTICS AND SHE FELT SOME IMPROVEMENT". IN (B)(6) 2013 (EXACT DATE UNKNOWN) THE PATIENT RETURNED TO THE HOSPITAL "SUFFERING WITH PAIN". THE PHYSICIAN PERFORMED A MAGNETIC RESONANCE IMAGING (MRI) WHICH REVEALED "SOME LESIONS ON THE UTERINE WALL". A LAPAROSCOPY WAS PERFORMED AND THE PHYSICIAN "VISUALIZED 2 DIATHERMY BURNS ADJACENT TO THE FALLOPIAN TUBES". THE PHYSICIAN NOTED "THERE WAS NO DAMAGE TO THE BOWEL OR OTHER ORGANS" AND NO ADHESIONS SEEN. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296504 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention RADIO FREQUENCY CONTROLLER - 33143E12DO