BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 4173236 · Received September 19, 2014

    Report

    Report Number
    1222780-2014-00164
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 8, 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
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: SERIAL NUMBER OF THE RADIO FREQUENCE CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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 TO PERFORM A NOVASURE ENDOMETRIAL ABLATION AND HAD DIFFICULTY SEATING THE DISPOSABLE DEVICE. THE NOVASURE PROCEDURE WAS ABORTED AND THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH A COMPETITIVE DEVICE. A LAPAROSCOPY FOLLOWED AND A UTERINE PERFORATION WAS VISUALIZED. ON (B)(6) 2014, ADDITIONAL INFORMATION WAS RECEIVED. RISK MANAGEMENT REPORTED THE "PATIENT HAD A HYSTERECTOMY AND WAS DISCHARGED THE FOLLOWING DAY". DILATION AND SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED NOVASURE. 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
    583279 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 14D03RH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNKNOWN