BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS 1

    MDR report key: 851302 · Received May 9, 2007

    Report

    Report Number
    2914019-2006-00128
    Event Type
    Other
    Date Received
    May 9, 2007
    Date of Event
    January 17, 2006
    Report Date
    May 9, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LUMENIS CE VERIFIED THAT ALL FILTERS, LIGHT GUIDES, AND POWER METER FACES ARE CLEAN. VERIFIED ENERGY OUTPUT FOR BOTH IPL AND YAG HEADS ARE WITHIN SPEC. CALIBRATED BOTH HEADS AND CHECKED ENERGY OUTPUT AGAIN. ALL VALUES WITHIN SPEC. NO PROBLEMS FOUND. SYSTEM OK FOR USE. ROOT CAUSE: THE ROOT CAUSE APPEARS TO BE THAT THE PT IS A TRUE SKIN TYPE VI OR POSSIBLE SUN EXPOSURE; BOTH OF THESE FACTORS ARE LISTED IN THE LUMENIS ONE OPERATOR MANUAL AS CONTRAINDICATIONS FOR IPL TREATMENT WITH THE LUMENIS ONE DEVICE. 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

    PER THE CUSTOMER, A SKIN TYPE V (BORDERLINE SKIN TYPE VI) PT HAD BLISTERS AFTER IPL TREATMENT WITH THE LUMENIS ONE TO ACNE SCARS ON THE BACK. PER THE CUSTOMER, THE PT WAS TEST SPOTTED PRIOR TO THE TREATMENT. THE PHYSICIAN ALSO HAD A REACTION (MODERATE ERYTHEMA, HYPERPIGMENTATION, CRUSTING AND HYPOPIGMENTATION) WHEN HE WAS UNDERGOING IPL HAIR REMOVAL WITH THE LUMENIS EARLIER IN 2006. THE CUSTOMER STATED, THAT THEY THINK THE PRESETS ARE TOO AGGRESSIVE.

    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 LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention NONE REPORTED