BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 22068897 · Received May 22, 2025

    Report

    Report Number
    22068897
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE MOXY GREENLIGHT LASER FIBER. ¿EXCESSIVE FIBER ACTIVITY. PLEASE CLEAN AND INSPECT FIBER TIP¿ MESSAGE SHOWED BEGINNING OF THE PROCEDURE. EVEN LESS THAN A COUPLE OF MINUTES AFTER STARTED. CHANGED ANOTHER FIBER AND THE CASE PROCEEDED WITHOUT PROBLEM. AFFECTED PRODUCT: REF # 0010-2400, LOT # 35540246, EXP 2027-01-02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818982 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 35540246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown