BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER FIBER 200 MICRON

    MDR report key: 10343924 · Received July 29, 2020

    Report

    Report Number
    MW5095805
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 24, 2020
    Report Date
    July 28, 2020
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LASER FIBER BROKE WITHIN URETEROSCOPE 1" FROM DISTAL TIP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805952 LASER FIBER 200 MICRON POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC 19219004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other