BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2518048 · Received March 30, 2012

    Report

    Report Number
    1222780-2012-00070
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 2, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 RADIO FREQUENCY CONTROLLER (RFC) WAS RECEIVED ON (B)(4) 2012. THE DISPOSABLE 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. THE MANUFACTURE DATE OF THE RFC IS 08/2007. DEVICE HISTORY RECORD (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

    FOLLOWING THREE UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS, THE PHYSICIAN COMPLETED A NOVASURE ENDOMETRIAL ABLATION. HE THEN DID A HYSTEROSCOPY AND SAW A "PERFORATION AT THE RIGHT UTERINE FUNDUS." A LAPAROSCOPY FOLLOWED AND HE NOTED THE "UTERUS HAD CHARRING ACROSS THE FUNDUS EXTENDING TO THE RIGHT CORNUAL REGION. OMENTAL ADHESIONS WERE NOTED ATTACHING TO THE UTERINE FUNDUS" WHICH HE THEORIZED "MAY HAVE BLOCKED THE UTERINE PERFORATION FROM LEAKING CO2 ON THE FOURTH CIA ATTEMPT." ADDITIONALLY, "THE ENTIRE BOWEL WAS INSPECTED AND NO THERMAL INJURIES WERE IDENTIFIED." NO TREATMENT WAS NEEDED AND THE PATIENT WAS DISCHARGED HOME. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED (NAME OF MEDICATION AND DOSE UNKNOWN). THE PHYSICIAN REPORTED HE "SUSPECTED THAT THE PATIENT WAS PREDISPOSED TO UTERINE PERFORATION DUE TO POOR TISSUE QUALITY AS EVIDENCED BY THE FRIABLE CERVIX WHICH ULTIMATELY REQUIRED A SUTURE TO CONTROL THE BLEEDING."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other RADIO FREQUENCY CONTROLLER: SERIAL NUMBER (B)(4)