BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3478560 · Received November 13, 2013

    Report

    Report Number
    1222780-2013-00203
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    October 17, 2013
    Report Date
    October 17, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. MANUFACTURE DATE FOR THE RADIO FREQUENCY CONTROLLER (RFC) - (B)(6) 2011. DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR BOTH THE DISPOSABLE DEVICE AND RFC REPORTEDLY USED IN THIS PROCEDURE. NO ABNORMALITIES NOTED AND UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION. ON POST-ABLATION HYSTEROSCOPY, "FLUFFY TISSUE WAS NOTED WHICH OBSCURED A COMPLETE VIEW OF THE CAVITY BUT THERE WERE NO PERFORATION SEEN AND THERE WAS GOOD UTERINE DISTENSION". THE PHYSICIAN THEN PERFORMED A LAPAROSCOPY FOR TUBAL STERILIZATION AND THE UTERINE FUNDUS WAS INSPECTED AND THERE APPEARED TO BE 2 CIRCULAR BLANCHED AREAS BILATERALLY AT THE TOP OF THE FUNDUS. IN ONE CIRCULAR AREA, THERE WAS A CENTRAL FOCUS OF CHARRING. THE PHYSICIAN CONSULTED A GENERAL SURGEON WHO ASSISTED WITH THE INSPECTION OF THE ENTIRE BOWEL; NO BOWEL INJURIES WERE IDENTIFIED. THE PT WAS KEPT OVERLIGHT FOR OBSERVATION AND A DRAIN WAS PLACED INTO THE ABDOMEN WHICH THE SURGEON INTENDS TO REMOVE IN 3-4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588455 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 13G18RB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - 32088E11D0