BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD LASER

    MDR report key: 1293920 · Received January 21, 2009

    Report

    Report Number
    MW5009684
    Event Type
    Malfunction
    Date Received
    January 21, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 21, 2009
    Manufacturer
    MEDICAL ENERGY, INC.
    Product Code
    EWG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USING A GOLD LASER SYSTEM -LF 20- TO PERFORM T&A. INSERTED LASER TRANSNASALLY TO ABLATE ADENOIDS AND NOTED VERY SMALL BALL TIP -2.3MM- OF THE LASER WAND WAS MISSING. ATTEMPTS MADE TO FIND THE TIP INCLUDING NASAL ENDOSCOPY, DIRECT LARYNGOSCOPY, STRAINING SUCTION APPARATUS CONTENTS, AND EVALUATING PATHOLOGY MATERIAL WERE UNSUCCESSFUL. CALLED COMPANY - REP FOR LASER CENTER INDICATED THE TIP IS INERT AND NOT RADIOPAQUE, THEREFORE, UNTRACEABLE. STATED IN THE PAST, WHEN TIPS HAD BROKEN, THERE WERE NO LONG TERM PROBLEMS. STATED IF IT WAS IN THE NOSE OR NASOPHARYNX, IT WOULD WORK ITS WAY OUT. SURGEON DID NOT SEE TIP ON REPEAT DILIGENT EXAMS. DIAGNOSIS OR REASON FOR USE: T & A. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD LASER LIGHTFORCE LF20 EWG MEDICAL ENERGY, INC. LF 20 "GOLD" LASER 3028A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR