BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE STERILIZED AND SURESOUND

    MDR report key: 17239305 · Received June 30, 2023

    Report

    Report Number
    1222780-2023-00222
    Event Type
    Death
    Date Received
    June 30, 2023
    Date of Event
    June 21, 2023
    Report Date
    June 30, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. D4: LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE 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. H3: THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A NOVASURE PROCEDURE WAS PERFORMED, AND THE PROCEDURE WENT FINE WITH NO ISSUE, THE PATIENT WAS DOING WELL. THE PATIENT WAS SCHEDULED FOR A SALPINGECTOMY IMMEDIATELY AFTER THE NOVASURE PROCEDURE. WHILE THE TROCARS WERE BEING PLACED UNFORTUNATELY A CODE BLUE (CARDIAC ARREST) WAS REPORTED RELATED TO THE PATIENT AND ALL MEASURES WERE TAKEN TO PERFORM CPR. THE PATIENT WAS UNABLE TO BE REVIVED AND PASSED AWAY. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20074 NOVASURE STERILIZED AND SURESOUND DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC 2013

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death