BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3122520 · Received May 16, 2013

    Report

    Report Number
    1222780-2013-00092
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    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. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. 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 RECEIVED (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 ON (B)(6) 2013, A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION ON A PT WITH A "RETROFLEXED UTERUS". NO POST HYSTEROSCOPY WAS DONE. THE PT WAS DISCHARGED. ON (B)(6) 2013, THE PT PRESENTED TO THE HOSPITAL WITH "SEVERE STOMACH PAIN". THE PT WAS ADMITTED AND "ON DAY 4, A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THERE WAS A PERFORATION". A LAPAROTOMY WAS PERFORMED AND REVEALED "INTRA ABDOMINAL FECES AND INFLAMMATION". ADDITIONALLY, A 2CM "HOLE WAS IN THE UTERUS AND A 2CM PERFORATION IN THE SIGMOID DUE TO NECROSIS". A "BOWEL RESECTION" WAS PERFORMED. THE PT REMAINS IN THE HOSPITAL WITH COLOSTOMY BAG. NO INTERVENTION REQUIRED FOR THE UTERINE PERFORATION. ON (B)(4) 2013, IT WAS REPORTED THE PT IS DOING WELL UNDER THE CIRCUMSTANCES. SHE CURRENTLY STILL HAS THE COLOSTOMY IN PLACE. THE PHYSICIAN WILL TRY TO REVERSE THE COLOSTOMY AFTER 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217760 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK