BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH

    MDR report key: 17372551 · Received July 21, 2023

    Report

    Report Number
    1222780-2023-00253
    Event Type
    Death
    Date Received
    July 21, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 21, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    UDI-DI
    15420045504530
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 JULY 17TH 2023, DURING A MYOSURE REACH PROCEDURE USING AQUILEX AS FLUID MANAGEMENT SYSTEM, THE PROCEDURE WAS GOING NORMAL AND THE DEFICIT WAS APPROXIMATELY AT 1300ML WHEN THE PHYSICIAN REPORTED A POSSIBLE PERFORATION. AT THIS POINT THE DEFICIT ROSE QUICKLY AND AT 2500 ML THE DOCTOR STOPPED THE PROCEDURE. THE TM LEFT THE ROOM SINCE THE PHYSICIAN MENTIONED THAT THE PATIENT WAS GOING TO RECEIVE A ECHOCARDIOGRAM AND SOME ADDITIONAL TESTS. THIS HAPPENED AT 9AM. LATER THAT DAY THE PATIENT WAS SADLY PRONOUNCED DEATH. THE CAUSE OF DEATH WAS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921437 MYOSURE REACH HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 10-401FC 15420045504530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death AQL-100P