BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 7447404 · Received April 20, 2018

    Report

    Report Number
    1222780-2018-00072
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    March 22, 2018
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. 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 IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: ·THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICE WAS NOT RETURNED. TWO RADIO FREQUENCY CONTROLLERS WERE RETURNED: ON (B)(6) 2018, THE RFC CONTROLLER ((B)(4)) WAS INVESTIGATED AND CONTROLLER PASSED ALL FUNCTIONAL TESTING. ON (B)(6) 2018 , THE RFC CONTROLLER ((B)(4)) WAS INVESTIGATED AND CONTROLLER PASSED ALL FUNCTIONAL TESTING. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLERS. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION SOMETIME IN (B)(6) 2018 (EXACT DATE UNKNOWN) AND THE PATIENT WAS DISCHARGED HOME. "APPROXIMATELY 10 DAYS POST-PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND WAS TREATED FOR PRESUMED INFECTION AND SENT HOME. SHE RETURNED 24 HOURS LATER WITH INCREASING PAIN AND WAS ADMITTED FOR FURTHER EVALUATION. A CT-SCAN DEMONSTRATED A HEMATOMA IN THE ABDOMINAL CAVITY. SHE WAS TAKEN TO THE OPERATING ROOM AND DRAINED OF 1700CC OF BLOOD. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE SURGICAL FINDINGS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290284 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC, INC. NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RADIO FREQUENCY CONTROLLER: UNK