BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS ONE

    MDR report key: 831430 · Received March 15, 2007

    Report

    Report Number
    2914019-2005-00108
    Event Type
    Other
    Date Received
    March 15, 2007
    Report Date
    March 15, 2007
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS CUSTOMER ENGINEER CE, THE DEVICE CALIBRATION WAS ABOUT 25% HIGH. APPARENTLY, THE CUSTOMER HAD CALIBRATED THE DEVICE WHILE THE TREATMENT HEAD WAS NOT FULLY SEATED IN ITS CRADLE. THIS WOULD HAVE RESULTED IN OUTPUT ABOUT 25% HIGH AS DUPLICATED BY THE CE. IN ADDITION, THE CE SUSPECTED A POSSIBLE MALFUNCTION OF THE TREATMENT HEAD. THE CUSTOMER REPLACED THE TREATMENT HEAD AND THE CE INSTALLED THE NEW TREATMENT HEAD ON A FOLLOW-UP SERVICE CALL. THE ELEVATED DEVICE OUTPUT APPEARS TO BE THE ROOT CAUSE OF THE INCIDENTS. 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 THAT THREE PTS HAD BEEN BURNED. TWO PTS WERE BURNED ON THE LEGS WHEN TREATED FOR MATTING AND VEINS AND ONE PT TREATED FOR POIKILODERMA ON CHEST. PRIOR TO THESE INCIDENTS, THE CUSTOMER HAD GOOD SUCCESS WITH TREATMENTS FOR MATTED VEINS. ONLY OTC PRODUCTS (NEOSPORIN, CU3 CREAM) WERE RECOMMENDED FOR THE BURNS. ADD'L DETAILS SUCH AS TREATMENT PARAMETERS AND INCIDENT DATES WERE REQUESTED BY LUMENIS AND WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED