BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    940U LASER FIBER PL

    MDR report key: 20049723 · Received August 22, 2024

    Report

    Report Number
    MW5158786
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    May 10, 2024
    Report Date
    August 20, 2024
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN SURGEON INSERTED LASER FIBER INTO CYSTOSCOPE, A PIECE OF THE LASER FIBER BROKE OFF INTO THE BLADDER. IT WAS RETRIEVED WITH A GRASPER. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276207 940U LASER FIBER PL POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS LLC. 8000232 DK21049

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male