BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA

    MDR report key: 3592502 · Received November 21, 2013

    Report

    Report Number
    3592502
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 21, 2013
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATIVE PROCEDURE STAFF SMELLED AN ACRID ODOR AND SMOKE COMING FROM THE TOWER OF A CO2 LASER. THEY IMMEDIATELY TURNED OFF THE LASER AND UNPLUGGED IT FROM THE WALL. IT WAS TAKEN OUT OF THE OR. FLAMES WERE SEEN INSIDE THE PANEL AND THE FIRE WAS EXTINGUISHED BY THE DR. WITH A COMPRESSED NITROGEN FIRE EXTINGUISHER. NO HARM OR INJURY CAME TO THE PATIENT OR STAFF.======================MANUFACTURER RESPONSE FOR CO2 LASER, MD80 CO2 LASER (PER SITE REPORTER).======================MANUFACTURER TECHNICAL REP HAS INVESTIGATED THE LASER AND IT WAS DETERMINED THAT A POORLY FASTENED TUBE ALLOWED COOLANT TO LEAK. THE COOLANT IGNITED AROUND THE ANODE OF THE LASER CAUSING THE FIRE.THE REP ALSO STATED THERE IS A NEW SOFTWARE VERSION FOR IMPROVED PATIENT, STAFF AND EQUIPMENT SAFETY. THE SOFTWARE DISABLES THE POWER PEDDLE OPERATION IN THE EVENT OF A FAILURE. IT IS NOT CLEAR IF THE SOFTWARE IS A SIMPLE UPDATE OR IF AN UPGRADE MUST BE PURCHASED. HOWEVER, THE SIGNIFICANT SAFETY IMPROVEMENT OF REMOVING POWER TO THE LASER SHOULD AT A MINIMUM WARRANT A COMMUNICATION TO ALL STAKEHOLDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607465 ULTRA POWERED LASER SURGICAL GEX LASER ENGINEERING, INC. MD 80 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR TIME THAT MIGHT HAVE CONTRIBUTED TO THE EVENT.| NO, THERE WERE NO OTHER DEVICES BEING USED AT THE