BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 22212851 · Received June 16, 2025

    Report

    Report Number
    1222780-2025-00331
    Event Type
    Death
    Date Received
    June 16, 2025
    Date of Event
    May 22, 2025
    Report Date
    September 1, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    UDI-DI
    15420045505094
    PMA / PMN Number
    K142029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO PROVIDED FROM THE FIELD: THE FORENSIC REPORT WAS NOT CONDUCTED, AND THE CASE HAS BEEN OFFICIALLY CLOSED. THE INVESTIGATION FROM THE DISTRIBUTOR CONCLUDED THAT THE PATIENT¿S PASSING WAS NOT RELATED TO MYOSURE OR THE PRODUCT IN GENERAL AND THE HOSPITAL DID NOT FIND ANY RELATIONSHIP ON THE PRODUCT EITHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT RECEIVED A MYOSURE XL PROCEDURE ON A 40 YEAR-OLD PATIENT, DURING THE PROCEDURE UP UNTIL 17 MINUTES EVERYTHING WAS DOING WELL AND TOTAL AMOUNT OF FLUID WAS 5 LITERS AND 3 LITERS SPILLED OUT OF THE PATIENT. THE HYSTEROSCOPE WAS REMOVED FROM THE PATIENT´S BODY AND THE PROCEDURE WAS ALMOST COMPLETE WHEN THE PATIENT SUDDENLY DEVELOPED ARRHYTHMIA AND AFTER 25 MINUTES OF RESUSCITATION FROM THE TEAM , THE PATIENT WAS TRANSFERRED TO THE ICU BUT DIED THE NEXT DAY. ECHOCARDIOGRAPHY WHICH DID NOT REVEAL ANYTHING. AN ABDOMINAL ULTRASOUND WAS PERFORMED AND THERE WERE NO PROBLEMS OBSERVED. PATIENT HAD A PREVIOUS HISTORY OF A MYOMECTOMY WITH RESECTOSCOPE A MONTH PRIOR TO THE PROCEDURE. THE PHYSICIAN BELIEVED THAT THE OPERATION WAS WELL PERFORMED AND THAT THE PATIENT´S DEATH HAD NOTHING TO DO WITH THE MYOSURE. THE FLUID MANAGEMENT SYSTEM WAS NOT A HOLOGIC PRODUCT. NO OTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683320 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 50-501XL 24C15RD 15420045505094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death