BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3883934 · Received June 13, 2014

    Report

    Report Number
    1222780-2014-00093
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPLAINT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. REFERENCE INTERNAL COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN EXPERIENCED DIFFICULTY SEATING THE ELECTRODE ARRAY. POST DEVICE SEATING, THE PHYSICIAN RECEIVED SEVERAL UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS. THE DEVICE WAS REMOVED AND "UPON THE HYSTEROSCOPY THE PHYSICIAN FOUND A PERFORATION AT THE MIDLINE OF THE FUNDUS". THE NOVASURE PROCEDURE WAS ABORTED. THE PHYSICIAN PRESCRIBED ANTIBIOTICS AND THE PATIENT WAS DISCHARGED HOME. A HYSTEROSCOPY, DILATATION, AND SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350452 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK