BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1962517 · Received January 6, 2011

    Report

    Report Number
    1222780-2011-00002
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THIS DEVICE CAN NOT BE COMPLETED. MANUFACTURE DATE OF THE RADIO FREQUENCY CONTROLLER IS 10/2006. EVAL: DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR BOTH THE DISPOSABLE DEVICE AND RF CONTROLLER. NO ABNORMALITIES WERE NOTED AND THE DEVICES WERE RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. 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

    A PT HAD A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2010. A POST HYSTEROSCOPY SHOWED "GOOD ABLATION AND NO PERFORATION". THE NEXT DAY THE PT REPORTED "PAIN AND CRAMPING" RELIEVED WITH VICODIN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN). TWO WEEKS POST ABLATION SHE WENT TO THE EMERGENCY ROOM (ER) WITH PELVIC PAIN, TENDERNESS ON PELVIC EXAM, FEVER OF 102 DEGREES FAHRENHEIT, RIGORS, AND PURULENT DRAINAGE. HER WHITE BLOOD CELL (WBC) COUNT WAS "16,000 WITH A LEFT SHIFT". ON COMPUTED TOMOGRAPHY (CT) SCAN TWO "ADNEXAL MASSES" WERE SEEN, MEASURING 9CM ON THE LEFT SIDE AND 6CM ON THE RIGHT SIDE, "CONSISTENT WITH TUBO-OVARIAN ABSCESSES". "ADNEXAL MASSES" WERE NOT SEEN ON A PRE-NOVASURE ULTRASOUND. SHE WAS ADMITTED TO THE HOSPITAL AND TREATMENT INCLUDED INTRAVENOUS (IV) ANTIBIOTICS. CULTURES OF THE GENITAL TRACT AND BLOOD HAVE BEEN NEGATIVE. ON (B)(6) 2010, THE PHYSICIAN REPORTED THIS PT IS HOME ON ANTIBIOTICS AND SHE IS FEELING BETTER EACH DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10E11RA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER: SERIAL # (B)(4)