BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1561244 · Received December 14, 2009

    Report

    Report Number
    1561244
    Event Type
    Malfunction
    Date Received
    December 14, 2009
    Date of Event
    November 4, 2009
    Report Date
    December 14, 2009
    Manufacturer
    LASER PERIPHERALS LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE STATED THAT WHEN BEING USED ON THE PATIENT, THE LASER FIBER BROKE. IT APPEARS THAT THE FIBER BROKE OFF ABOUT 1/3 OF THE LENGTH TOWARDS THE PROXIMAL END. THERE WERE NO PIECES OR FRAGMENTS IDENTIFIED THAT COULD HAVE BEEN RETAINED. ANOTHER FIBER WAS OPENED AND THE PROCEDURE WAS COMPLETED. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER FIBER, HOLMIUM, SINGLE USE GEX LASER PERIPHERALS LLC HB-200 LP-548

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR