BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA MD CO2 LASER SYSTEM

    MDR report key: 3944668 · Received April 24, 2014

    Report

    Report Number
    3000204219-2014-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    November 12, 2013
    Report Date
    April 24, 2014
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    PMA / PMN Number
    K905676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LASER ENGINEERING WAS NOTIFIED OF THE FOLLOWING EVENT BY THE HOSPITAL ON (B)(6) 2013. DURING AN OPERATIVE PROCEDURE, THE STAFF SMELLED AN ODOR AND EXPERIENCED SMOKE COMING FROM THE TOWER OF THE CO2 LASER. THE LASER SYSTEM WAS SHUT DOWN, UNPLUGGED AND REMOVED FROM THE OPERATING ROOM. FLAMES WERE SEEN INSIDE THE TOWER COVER AND THE FIRE WAS EXTINGUISHED WITH A COMPRESSED NITROGEN FIRE EXTINGUISHER. THERE WAS NO REPORTED HARM TO PATIENT, HOSPITAL STAFF, OR FACILITY. LASER ENGINEERING IMMEDIATELY MADE PLANS TO INVESTIGATE THE LASER UNIT AT THE HOSPITAL. LASER ENGINEERING SENT THEIR SENIOR TECHNICIAN AND QUALITY CONTROL TO THE HOSPITAL ON (B)(6) 2013. AFTER INVESTIGATING IT WAS DETERMINED THAT THE MOUNT PANEL COUPLER WAS DISENGAGED. ELECTRICAL TAPE WAS ALSO USED AROUND THE COUPLER. WITH THE COUPLER NOT SEATED PROPERLY THIS CAUSED THE COOLANT TO LEAK DOWN ONTO THE HIGH VOLTAGE CONNECTION GOING TO THE TUBE AND CAUSED THE FIRE. AFTER TALKING WITH THE HOSPITAL WE COULD NOT DETERMINE IF THE LASER WAS LEAKING AND THE TAPE WAS ADDED TO STOP THE LEAK OR IF THE TAPE WAS ADDED AND CAUSED THE COUPLER TO DISENGAGE CAUSING THE LEAK. BASED ON PRIOR SERVICE REPORTS THERE WAS NO INDICATION OF ANY TYPE LEAK. FULL DETAIL OF THE INSPECTION ARE AVAILABLE AT LASER ENGINEERING, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248172 ULTRA MD CO2 LASER SYSTEM ULTRA MD80 GEX LASER ENGINEERING, INC. MD80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1