BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWER LASER FIBER 550 MICRON

    MDR report key: 24247114 · Received February 3, 2026

    Report

    Report Number
    MW5183244
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 16, 2026
    Report Date
    January 29, 2026
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FLAME WAS OBSERVED ON THE LASER FIBER NEAR THE CONNECTION TO THE LASER MACHINE. THE FLAME WAS IMMEDIATELY CALLED OUT AND EXTINGUISHED WITH A WET TOWEL. NO HARM OR INJURY TO PATIENT WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305955 EMPOWER LASER FIBER 550 MICRON POWERED LASER SURGICAL INSTRUMENT GEX OLYMPUS SURGICAL TECHNOLOGIES AMERICA H244320

    Patients

    Seq Age Sex Outcome Treatment
    1 Male