BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS 1

    MDR report key: 851301 · Received May 9, 2007

    Report

    Report Number
    2914019-2006-00102
    Event Type
    Other
    Date Received
    May 9, 2007
    Date of Event
    June 22, 2006
    Report Date
    May 9, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS CUSTOMER ENGINEER (CE), CHECKED DELIVERED FLUENCE WITH CALIBRATED POWER METER, IPL ENERGY APPROXIMATELY 7% LOW AND NDYAG ENERGY APPROXIMATELY 9% HIGH (IN SPECIFICATION). CE INSPECTED ALL ACCESSORY ITEMS INCLUDING FILTERS AND LIGHTGUIDES. NO NOTICEABLE DAMAGE TO ANY OF THE SUPPLIED ACCESSORIES. CE RECALIBRATED THE INTERNAL POWER METERS AND TREATMENT HEADS AND RE-CHECKED DELIVERED FLUENCE WITH CALIBRATED POWER METER. CE CLEANED ALL ACCESSORIES AND LIGHT GUIDES. ROOT CAUSE: THE CE WAS NOT ABLE TO DUPLICATE THE COOLING PROBLEM REPORTED BY THE CUSTOMER. NO FURTHER CONCLUSION CAN BE DRAWN REGARDING ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    THE PHYSICIAN HAS HAD SEVERAL PTS WITH FIRST TO SECOND DEGREE BURNS OR BLISTERING AND INSISTS THAT IT IS BECAUSE OF FAILED COOLING ON THE LUMENIS ONE IPL HEAD. PER THE PHYSICIAN, THE LIGHTSHEER MODULE WILL GO INTO DEFAULT WHEN NOT PROPERLY COOLED AND THE LUMENIS ONE IPL DOES NOT GIVE ANY INDICATION WHEN THE HEAD IS NOT COOLED (PER THE PHYSICIAN, THE GREEN LIGHT IS ALWAYS ON). SOME OF THE PTS HAVE PERSISTENT HYPERPIGMENTATION ON THEIR FACES, WHICH THE PHYSICIAN HAS TREATED WITH BLEACHING AGENTS (HYDROQUINONE 4%), KTP LASER, RUBY LASER AND/OR MICRODERMABRASION. PER THE PHYSICIAN, IT IS POSSIBLE THAT THE PIGMENT CHANGE WILL BE PERMANENT IN SOME OF THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS 1 COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER(S) GEX LUMENIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention NONE REPORTED