BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3853482 · Received May 29, 2014

    Report

    Report Number
    1222780-2014-00082
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON A PATIENT WITH AN ANTEVERTED UTERUS AND A PREVIOUS THERMAL ABLATION (EXACT DATE UNKNOWN). THE PHYSICIAN EXPERIENCED DIFFICULTY SEATING THE ELECTRODE ARRAY AND WHEN THE DEVICE WAS FINALLY SEATED, THE ARRAY "POPPED OPEN". THE DEVICE WAS REMOVED AND A HYSTEROSCOPY WAS PERFORMED. THE PHYSICIAN CONFIRMED A UTERINE PERFORATION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND DISCHARGED HOME. 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
    315664 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 13M13RF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention THS HYSTEROSCOPE: SN UNK| RADIO FREQUENCY CONTROLLER: SN UNK