BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 17142558 · Received June 16, 2023

    Report

    Report Number
    17142558
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 26, 2023
    Report Date
    May 31, 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

    MD NOTICED THAT THE FIBER WIRE WAS WEAK AND WAS GOING TO BREAK IF USED. IF THE FIBER WIRE HAD BEEN USED THERE WAS POTENTIAL THAT THE FIBER COULD HAVE BROKEN OFF INSIDE THE PATIENT. MD OPENED A NEW FIBER WIRE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551500 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DG22048 00816469021315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown