BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 4173235 · Received September 19, 2014

    Report

    Report Number
    1222780-2014-00163
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 20, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN ATTEMPTED A NOVASURE ENDOMETRIAL ABLATION AND HAD DIFFICULTY SEATING THE DEVICE. ONCE THE DEVICE WAS SEATED, THE PHYSICIAN RECEIVED SEVERAL CAVITY INTEGRITY ASSESSMENT (CIA) TEST FAILURES. A HYSTEROSCOPY WAS PERFORMED AND A UTERINE PERFORATION WAS VISUALIZED. THE PROCEDURE WAS ABORTED AND NO INTERVENTION WAS REQUIRED. THE PATIENT WAS DISCHARGED HOME. A HYSTEROSCOPY, DILATION, 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
    583014 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 14306RD

    Patients

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