BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2122965 · Received June 9, 2011

    Report

    Report Number
    1222780-2011-00105
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION, A HYSTEROSCOPY WAS DONE AND A FUNDAL UTERINE PERFORATION WAS SEEN. A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND THE PERFORATION, "WITH CAUTERY EFFECT", WAS CONFIRMED. THE PHYSICIAN EXAMINED THE BOWEL AND NO PERFORATION OR THERMAL INJURY WAS SEEN. THE PT WAS ADMITTED FOR 24 HOUR OBSERVATION. ON (B)(6) 2011, THE PHYSICIAN'S NURSE REPORTED THE PT WAS DISCHARGED HOME THE NEXT DAY AND IS "DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10M18RA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK