BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PERIPHERALS SCATTERFREE FIBERS

    MDR report key: 10600107 · Received September 28, 2020

    Report

    Report Number
    MW5096922
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 24, 2020
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OPERATING ROOM FOR TRANSURETHRAL RESECTION OF BLADDER NECK CONTRACTURE WITH HOLMIUM LASER. LASER FIBER MALFUNCTIONED/BROKE OUTSIDE OF THE PATIENT WHILE IN USE. BROKEN LASER FIBER REMOVED FROM FIELD. NO APPARENT HARM CAUSED TO PATIENT. SURGERY RESUMED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059511 LASER PERIPHERALS SCATTERFREE FIBERS POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC DC20094

    Patients

    Seq Age Sex Outcome Treatment
    1