BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT ELITE

    MDR report key: 913089 · Received March 16, 2007

    Report

    Report Number
    2914019-2005-00070
    Event Type
    Other
    Date Received
    March 16, 2007
    Date of Event
    July 1, 2005
    Report Date
    March 16, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER LUMENIS SVC, THE VASCULIGHT ELITE DEVICE WAS WELL CALIBRATED AND OPERATED NORMALLY; THE PROBLEM WAS WITH THE SR TREATMENT HEAD THIS TREATMENT HEAD WAS GIVING A SIMMER ERRPR AND THE HEAD, ALONG WITH ITS 590 NM FILTER, WAS BADLY BURNT AND PITTED FROM THE GEL NOT BEING CLEANED OFF AND THERE WAS ALSO MAJOR DAMAGE TO THE FILTER COATING. AT LEAST ONE OTHER FILTER ALSO HAD GEL AND PITTING. USE OF THE DAMAGED FILTER APPEARS TO BE THE ROOT CAUSE FOR THE INJURY. AFTER THE SR HEAD AND THE 590 NM FILTER WERE REPLACED, THE DEVICE'S OPERATION WAS FOUND TO BE WITHIN SPECS. THE CUSTOMER ENGINEER ADVISED THE CUSTOMER REGARDING THE MAINTENANCE PROBLEMS WITH THEIR FILTERS. THE SIMMER ERROR WAS NOT RELATED TO THE SAFETY INCIDENT, PER LUMENIS SVC. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE.

    Description of Event or Problem · 1

    PER THE CUSTOMER, DURING TREATMENT TO THE TIP OF PT'S NOSE, THE VASCULIGHT ELITE TREATMENT HEAD OVERHEATED AND THE CRYSTAL BURNT. ERROR (LEFT HEAD FAILURE) AND POSSIBLE SIMMER ERROR FAILURE APPEARED. PER THE CUSTOMER, THE PT'S FACE SEEMED A LITTLE REDDER THAN USUAL, BUT AT THE TIME THE PT LEFT THE CUSTOMER LOCATION THERE WAS NO ACUTAL BURN. PER CUSTOMER, THERE WAS NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT ELITE ANESTHETIC LASER GEX LUMENIS, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other