BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE INPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2961745 · Received January 16, 2013

    Report

    Report Number
    1222780-2013-00005
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. CONCOMITANT MEDICAL PRODUCTS: 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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN REMOVED THE DISPOSABLE DEVICE AND NOTED "SOME OF THE MESH ON THE ARRAY WAS TORN OFF AT THE BOTTOM OF THE ARRAY." A HYSTEROSCOPY WAS DONE BUT THE MISSING PIECE WAS NOT FOUND IN THE CAVITY. THE PATIENT "WAS FINE" AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23758 NOVASURE INPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNKNOWN

    Patients

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