BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 16232205 · Received January 24, 2023

    Report

    Report Number
    16232205
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 16, 2023
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    UDI-DI
    00816469021315
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE FIBER BROKE AND WORE OUT FASTER THAN EXPECTED. CONTINUED TO OPEN ANOTHER FIBER THAT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300915 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DG22048 00816469021315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown