BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3143057 · Received May 23, 2013

    Report

    Report Number
    1222780-2013-00095
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. 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 COMPLAINANT, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. REFERENCE INTERNAL COMPLAINANT CC# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION IN (B)(6) 2013 (EXACT DATE UNKNOWN) THE PHYSICIAN PERFORMED A LAPAROSCOPY FOR ASSURE PLACEMENT AND THEN STARTED THE ABLATION. "AFTER ABOUT 90 SECONDS OF BURNING [ABLATION], WE SAW THE WHITE TIP OF ONE OF THE ARMS OF THE ARRAY PROTRUDING THROUGH THE SEROSA." THE PHYSICIAN STOPPED THE PROCEDURE WHEN SHE "SAW THE ARRAY HAD PERFORATED" VIA LAPAROSCOPE WHICH WAS STILL IN PLACE. NO ADDITIONAL INFORMATION PROVIDED. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229958 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNKNOWN

    Patients

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