BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3760965 · Received April 10, 2014

    Report

    Report Number
    1222780-2014-00058
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 12, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. 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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION (EXACT DATE UNKNOWN) AND RECEIVED THREE UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS. "SHE THEN PERFORMED A LAPAROSCOPY AND NOTED A PERFORATION IN THE UPPER CORNUA REGION". THERE WAS NO OTHER INJURY TO THE PATIENT. THE ATTEMPTED NOVASURE PROCEDURE WAS ABORTED. THE PHYSICIAN CAUTERIZED THE PERFORATION AND THE PATIENT IS DOING WELL. ON (B)(6) 2014. IT WAS REPORTED THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. THE PATIENT IS DOING "FINE NOW". A HYSTEROSCOPY, DILATATION, 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
    216158 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

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