BEUDAMED
    FDA Adverse Event Other Summary report: N

    1221336-2007-00001

    MDR report key: 889430 · Received July 24, 2007

    Report

    Report Number
    1221336-2007-00001
    Event Type
    Other
    Date Received
    July 24, 2007
    Product Code
    FST
    PMA / PMN Number
    K864385
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A LIGHT SOURCE PROVIDES LIGHT WHICH IS A SOURCE OF HEAT. THE LUXTEC LIGHT SOURCE HAS BEEN DESIGNED TO MINIMIZE THE AMOUNT OF HEAT IT GENERATES, BUT THE EQUIPMENT USED WITH THE LIGHT SOURCE MUST BE DESIGNED TO MATE PROPERLY WITH THE LIGHT SOURCE TO AVOID HEAT GENERATION FROM STRAY LIGHT. EQUIPMENT USED WITH A LIGHT SOURCE MUST ALSO BE DESIGNED PROPERLY TO PREVENT PARTS OF THE EQUIPMENT FROM HEATING UP, CAUSING A POTENTIAL FOR PT BURNS. THE USERS MANUAL WARNS THE USER ABOUT PROPER USE OF THE LIGHT SOURCE TO PREVENT PT INJURY. THE LIGHT SOURCE IS NOT DESIGNED TO BE IN CONTACT WITH THE PT AND THIS EVENT DOCUMENTATION DOES NOT IDENTIFY A MALFUNCTION OF THE LIGHT SOURCE. LUXTEC CAN ONLY CONCLUDE THAT THE EQUIPMENT USED WITH THE LIGHT SOURCE WAS NOT DESIGNED OR USED PROPERLY TO AVOID THE HEATING UP OF PARTS OF THE EQUIPMENT WHICH LEAD TO PT BURNS. LUXTEC CONTACTED THE USER FACILITY ON 06/28/2007, BUT THE FACILITY WOULD OFFER NO FURTHER INFO ON THE INCIDENT. NO PRODUCT WAS RETURNED TO LUXTEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FST

    Patients

    Seq Age Sex Outcome Treatment
    1