BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASULIGHT SR

    MDR report key: 831688 · Received March 15, 2007

    Report

    Report Number
    2914019-2005-00109
    Event Type
    Other
    Date Received
    March 15, 2007
    Date of Event
    November 2, 2005
    Report Date
    March 15, 2007
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER LUMENIS SERVICE, THE VASCULIGHT DEVICE WAS OUT OF CALIBRATION AND NEEDED AN ENERGY METER FACTOR CALIBRATION. IN ADDITION, PER THE CUSTOMER ENGINEER CE, THE SR AND FAST EPI TREATMENT HEADS WERE OUT OF SPECIFICATION. THE CUSTOMER ENGINEER CE PERFORMED THE ENERGY METER FACTOR CALIBRATION. THE TREATMENT HEADS WERE REPLACED. THE SR HEAD WAS REPLACED BY LUMENIS UNDER WARRANTY. THE FAST EPI HEAD WAS REPLACED BY CUSTOMER; LUMENIS RECOMMENDS REPLACEMENT OF TREATMENT HEADS THAT ARE PAST THE LUMENIS WARRANTY SHOT COUNT. ROOT CAUSE APPEARS TO BE HIGH OUTPUT FROM THE TREATMENT HEADS, POSSIBLE HIGH OUTPUT FROM THE VASCULIGHT DEVICE THAT WAS OUT OF CALIBRATION, OR A COMBINATION OF THESE FACTORS. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED JULY 25, 2006.

    Description of Event or Problem · 1

    PER CUSTOMER, UNIT GIVING TOO MUCH HEAT, WHEN USER WAS DOING A CASE ON A PT'S ARM, THE PT REC'D A FIRST DEGREE BURN WITH A SECOND DEGREE BURN IN THE AREA OF A SUNSPOT. PT INSISTED ON CONTINUING WITH IPL TREATMENT TO FACE DESPITE BURN TO ARM. PT DID NOT REACT TO THE TEST SPOT ON THE FACE, BUT DEVELOPED A PURPLE CRYSTAL MARK ON THE NEXT PULSE. THE PT WAS PRESCRIBED ALOE VERA GEL WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASULIGHT SR AESTHETIC LASER GEX LUMENIS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention NONE REPORTED