BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMIUM LASER FIBER

    MDR report key: 2013450 · Received March 7, 2011

    Report

    Report Number
    MW5019686
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 28, 2011
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE BEGINNING OF LASER PROCEDURE, THE LASER WAS FIRED AND EFFECT WAS OBSERVED ON FIRST ATTEMPT. DURING THE SECOND FIRING, OUTPUT WAS REDUCED AND AIMING BEAM WAS OBSERVED BY ANESTHESIOLOGIST OFF THE LEFT SIDE OF THE O.R. TABLE. LASER WAS PLACED ON STANDBY, PROCEDURE WAS PAUSED, LASER FIBER WAS INSPECTED BY LASER OPERATOR. FOUND TO BE BROKEN. LASER FIBER WAS REMOVED AND REPLACED. PATIENT WAS INSPECTED FOR INJURIES NEAR THE SITE OF THE FIBER BREAKAGE AND NO APPARENT INJURIES WERE NOTED BY THE LASER OPERATOR, O.R. NURSE, OR ANESTHESIOLOGIST. PROCEDURE WAS THEN RESUMED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLMIUM LASER FIBER LASER FIBER GEX LASER PERIPHERALS, LLC HB-200 LP-596

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR