BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE

    MDR report key: 23485284 · Received November 6, 2025

    Report

    Report Number
    23485284
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 17, 2025
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A 200 MICRON LASER FIBER WAS OPENED AND PLUGGED IN. AFTER STARTING TO LASE, THE PHYSICIAN NOTICED THAT THERE WAS A DEFECT IN THE LASER FIBER OUTSIDE THE BODY. IT WAS DETERMINED THAT THIS COULD RESULT IN HARM, SO THE LASER FIBER WAS TAKEN OFF THE FIELD, AND A NEW LASER FIBER WAS OPENED. IT WAS DETERMINED THE INITIAL FIBER WAS LIKELY DAMAGED PRIOR TO BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693276 SOLTIVE POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, LLC TFL-FBX200BS KR500872

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male