BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT HR

    MDR report key: 851299 · Received May 9, 2007

    Report

    Report Number
    2914019-2005-00062
    Event Type
    Other
    Date Received
    May 9, 2007
    Date of Event
    March 1, 2005
    Report Date
    May 9, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS SYSTEM POWER LEVEL 20% OVER THE REQUESTED ENERGY WHICH IS JUST WITHIN THE ALLOWED +/- 20% VARIATION IN OUTPUT. THE LUMENIS CUSTOMER CE RESET SYSTEM POWER LEVEL; RECALIBRATED MACHINE; EVERYTHING CHECKED OUT OKAY AFTER THE DEVICE SERVICE. THE CAUSE OF THE ELEVATED ENERGY OUTPUT COULD NOT BE DETERMINED BY THE CE. PER THE CE, THERE WAS NO VISIBLE FOREIGN MATERIAL ON THE DEVICE THAT WOULD EXPLAIN THE HIGH OUTPUT. NO SERIOUS INJURY IS NOTED. BRUISING IS A POSSIBLE EXPECTED OUTCOME FROM THIS TYPE OF TREATMENT AND IS NOTED AS SUCH IN THE USER MANUAL. 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

    CUSTOMER REPORTED, PTS GOT BRUISED FROM EXCESSIVE OUTPUT POWER. PER THE INITIAL REPORT FROM THE CUSTOMER, ONE PT WAS GIVEN KENALOG INJECTION AND CREAM (STEROID) ON THE DATE OF TREATMENT. LUMENIS REQUESTED F/U DETAILS, WHICH WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT HR AESTHETIC LASER GEX LUMENIS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention NONE REPORTED