BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FIBER

    MDR report key: 17595524 · Received August 21, 2023

    Report

    Report Number
    MW5144827
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 17, 2023
    Manufacturer
    INNOVAQUARTZ LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ELECTIVE LASER LITHOTRIPSY WITH STONE EXTRACTION, IT WAS NOTED THAT THE LASER TIP BROKE OFF WHILE BEING UTILIZED. MD NOTICED IMMEDIATELY AND RETRIEVED BROKEN PIECE. USED SCOPE TO VISUALIZE AREA TO CONFIRM NO OTHER FRAGMENTS. BARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035644 LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC. LSU200PF 21621008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention