BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH TISSUE REMOVAL DEVICE

    MDR report key: 22841600 · Received August 19, 2025

    Report

    Report Number
    1222780-2025-00450
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 19, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    UDI-DI
    15420045504530
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 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. 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. 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 A PATIENT RECEIVED A NOVASURE/MYOSURE PROCEDURE ON THE EARLY WEEK OF (B)(6) 2025. THE EXACT DATE IS UNKNOWN. THE TREATING PHYSICIAN FROM THE PROCEDURE REPORTED THAT THE PROCEDURE HAD BEEN A SIMPLE AND UNEVENTFUL PROCEDURE. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL WITH LOWER PELVIC PAIN; PATIENT APPEARED WELL AT THE TIME. PATIENT HEALTH STARTED DETERIORATING AND WAS ADMITTED TO THE HOSPITAL. A LAPAROSCOPY WAS PERFORMED AND A LARGE HEMATOMA WAS FOUND IN THE LOWER PELVIC AREA. A VASCULAR TEAM WAS BROUGHT IN WHERE THEY PERFORMED A COIL PROCEDURE. THE VASCULAR TEAM REPORTED THAT THEY DID NOT WANT TO TOUCH OR STIMULATE THE HEMATOMA AT THE TIME. ON DAY 5 OF THE ADMISSION THE PATIENT WAS TAKEN TO GENERAL SURGERY AND THE SURGICAL TEAM NOTED THEY LIFTED THE UTERUS AND UNDER THE CUL-DE-SAC THEY NOTED AN AREA POSSIBLE BURNED. AT THIS POINT THE MEDICAL TEAM DETERMINED THAT THERE WAS NOTHING THEY COULD TO FOR THE PATIENT AND THE PATIENT PASSED AWAY LATER THAT DAY. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435860 MYOSURE REACH TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 10-401FC 15420045504530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death