BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMIUM LASER FIBER WIRE

    MDR report key: 21586648 · Received March 12, 2025

    Report

    Report Number
    MW5167594
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 7, 2025
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF HOLMIUM LASER FIBER WIRE BROKE OFF INSIDE PATIENT. ALL PIECES OF WIRE REMOVED FROM PATIENT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701380 HOLMIUM LASER FIBER WIRE POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC SU365PF 10124008

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male