BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER POWERTOUCH

    MDR report key: 668145 · Received December 9, 2005

    Report

    Report Number
    668145
    Event Type
    Malfunction
    Date Received
    December 9, 2005
    Date of Event
    November 10, 2005
    Report Date
    December 9, 2005
    Manufacturer
    MEDICAL ENERGY INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS BROUGHT TO THE OR FOR A BRONCHOSCOPY AND KTP LASER ABLATION OF AIRWAY GRANULOMA. THE KTP LASER WAS INSPECTED AND TESTED PER PROTOCOL PRIOR TO THE PROCEDURE STARTING. A 3.5 VENTILATING BRONCHOSCOPY WAS PLACED WITH THE KTP LASER FIBER BEING PASSED THROUGH THE SIDE PORT OF THE BRONCHOSCOPE. ONCE THE FIBER ENTERED THE AIRWAY, IT FRACTURED. THERE WERE THREE PIECES NOTED IN THE AIRWAY. A PARSON'S LARYNGOSCOPE WAS USED TO EXPOSE THE LARYNX WHILE OPTICAL FORCEPS WERE USED TO REMOVE THE THREE PIECES OF THE SHATTERED FIBER. THE ORIGINAL PLANNED PROCEDURE WAS THEN COMPLETED. THERE WAS NO INJURY TO THE PATIENT WHO WAS DISCHARGED HOME FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER POWERTOUCH LASER FIBER QUARTZ CONTACT DELIVERY SYSTEM GEX MEDICAL ENERGY INC * 1904

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO