BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3410539 · Received October 4, 2013

    Report

    Report Number
    1222780-2013-00181
    Event Type
    Death
    Date Received
    October 4, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 9, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 MFR DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW AND STERILE LOT REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2013. A POST ABLATION HYSTEROSCOPY WAS PERFORMED AND "DID NOT NOTE ANY PROBLEMS". THE PT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PT CONTACTED THE PHYSICIAN COMPLAINING OF "ABDOMINAL AND GAS PAINS". THE PHYSICIAN "INSTRUCTED HER HOW TO DEAL WITH THE PAIN (TYPE OF INTERVENTION IS UNK)". THE PT WAS NOT SEEN BY THE PHYSICIAN. ON (B)(6) 2013, THE PT PRESENTED TO THE EMERGENCY ROOM (ER) AND WAS "SEPTIC AND HAD A WHITE BLOOD CELL COUNT OF 1.4". THE PT EXPIRED IN THE OPERATING ROOM (OR). ON (B)(6) 2013, IT WAS REPORTED THAT THE PT HAD "3 UTERINE PERFORATIONS AND A BOWEL BURN" AND "THE TIME OF EXPIRATION WAS 5:43PM (ON (B)(6) 2013)". WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504305 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death RADIO FREQUENCY CONTROLLER: SN # UNK| THS-HYSTEROSCOPE: SN # UNK