BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUXTEC

    MDR report key: 1054631 · Received May 30, 2008

    Report

    Report Number
    1221336-2008-00002
    Event Type
    Other
    Date Received
    May 30, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 30, 2008
    Manufacturer
    INTEGRA LUXTEC, INC.
    Product Code
    EQH
    PMA / PMN Number
    K864385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A LUXTEC LIGHT SOURCE WAS REPORTED TO HAVE "VISIBLE FIRE AND SMOKE, ENOUGH TO SET OFF A SMOKE ALARM". PHOTO'S OF THE LIGHT SOURCE (AFTER THE INCIDENT) WERE PROVIDED BY THE USER. THE PHOTO'S SHOWED THE INSIDE OF THE LIGHT SOURCE AND THERE WAS NOT ONLY EVIDENCE OF THERMAL DAMAGE BUT EVIDENCE THAT THE LIGHT SOURCE HAD BEEN SIGNIFICANTLY MODIFIED SINCE IT HAD BEEN PURCHASED. THIS WAS CONFIRMED WHEN THE LIGHT SOURCE WAS RECEIVED AT LUXTEC. WE DID CONTACT THE ORIGINAL REPORTER OF THE INCIDENT AND HE STATED THE LIGHT SOURCE MUST HAVE BEEN IN THIS MODIFIED CONDITION SINCE BEFORE HIS FIRM WAS CONTRACTED WITH THE HOSPITAL WHICH WAS 2006. LUXTEC COULD NOT DETERMINE THE CAUSE OF THE FAILURE DUE TO THE SIGNIFICANT MODIFICATIONS MADE TO THE DEVICE. LUXTEC QA/RA HAS RETAINED THE LIGHT SOURCE AND CONTACTED LUXTEC SALES TO WORK WITH THE FACILITY TO REPLACE THE LIGHT SOURCE.

    Description of Event or Problem · 1

    A LUXTEC LIGHT SOURCE WAS REPORTED TO HAVE "VISIBLE FIRE AND SMOKE, ENOUGH TO SET OFF A SMOKE ALARM". THE USER ALSO REPORTED THAT NONE WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXTEC LIGHT SOURCE EQH INTEGRA LUXTEC, INC. LX300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1