BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 25236199 · Received May 20, 2026

    Report

    Report Number
    2124215-2026-27068
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, TWO FIBERS WERE USED AND BEGAN FORWARD FIRING AFTER A FEW MINUTES OF USE. A THIRD FIBER WAS AND IT WAS OVERHEATED AND STOPPED WORKING AFTER A FEW MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH A FOURTH FIBER WITHOUT PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294222 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0038237955 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown