BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1923596 · Received December 10, 2010

    Report

    Report Number
    1222780-2010-00195
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. SHOULD WE RECEIVE THE COMPLAINT DEVICE OR ADD'L INFO, A SUPPLEMENTAL MEDWATCH WITH THE RESULTS OF OUR ANALYSIS WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR THE NOVASURE DISPOSABLE DEVICE LOT NUMBER AND RF CONTROLLER SERIAL NUMBER USED IN THIS PROCEDURE. NO ABNORMALITIES WERE NOTED AND THE DEVICES PASSED ALL QA TESTING PRIOR TO RELEASE. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION PROCEDURE, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND NOTED A UTERINE PERFORATION. A LAPAROSCOPY CONFIRMED TWO SMALL "BURN HOLES" AT THE CORNERS OF THE FUNDUS AND AN "AREA BURN AT THE SMALL BOWEL". BOTH THE UTERINE PERFORATION AND SMALL BOWEL WERE OVER SEWN. THE PT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH PROPHYLACTIC ANTIBIOTICS. THE PT WAS DISCHARGED ON (B)(6) 2010, AND WAS REPORTED TO BE "FINE". WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10G15RC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R RADIO FREQUENCY CONTROLLER (B)(4)