BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT ELITE

    MDR report key: 829981 · Received March 13, 2007

    Report

    Report Number
    2914019-2005-00073
    Event Type
    Other
    Date Received
    March 13, 2007
    Date of Event
    June 23, 2005
    Report Date
    March 13, 2007
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE VASCULIGHT ELITE DEVICE. PER THE CUSTOMER ENGINEER CE, THE UNIT WAS WITHIN SPECIFICATION AND NO PROBLEMS WERE DETECTED WITH THE SYSTEM. THE CE WAS NOT ABLE TO DUPLICATE THE REPORTED PROBLEM WITH THE CHILL TIP. PER THE CE, THE CHILL TIP FROSTED AT THE EXPECTED ENDPOINT AND THE CHILLER VOLTAGES TESTED OK. ALSO, THE NDYAG HEAD CALIBRATED PROPERLY. LUMENIS REPLACED THE NDYAG HEAD AS A COURTESY TO THE CUSTOMER. PER THE OPERATOR MANUAL, THE REPORTED TREATMENT PARAMETERS (105-120 J) ARE TOO AGGRESSIVE FOR TREATING SHALLOW SMALL LEG VEINS ON TYPE III SKIN. AGGRESSIVE TREATMENT PARAMETERS CAN CONTRIBUTE TO BURNS. PER THE CE, ANOTHER POSSIBLE EXPLANATION OF ROOT CAUSE COULD BE THAT THE CUSTOMER INADVERTENTLY DISABLED THE CHILL TIP FEATURE ON THE TIP DURING THE PROCEDURE. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO 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

    CUSTOMER REPORTED SECOND DEGREE BURNS AND BLISTERS TO PT TREATED WITH NDYAG ON LEGS FOR VEIN TREATMENT. ACCORDING TO THE CUSTOMER, THE NDYAG HEAD STOPPED CHILLING HALFWAY THROUGH THE CASE. PER THE CUSTOMER, THE BLISTERS BECAME INFECTED AND THE PT WAS PRESCRIBED BOTH TOPICAL AND ORAL ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention REQUESTED AND NOT PROVIDED.