BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS ONE

    MDR report key: 830631 · Received March 13, 2007

    Report

    Report Number
    2914019-2005-00099
    Event Type
    Other
    Date Received
    March 13, 2007
    Report Date
    March 13, 2007
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE LUMENIS ONE DEVICE. PER THE CUSTOMER ENGINEER CE, THE IPL TREATMENT HEAD APPEARED TO EXHIBIT UNSTABLE OUTPUT RANGING FROM LOW TO HIGH OUT OF SPEC. PER THE CE, NO PROBLEMS WERE FOUND WITH THE LUMENIS ONE SYSTEM. LUMENIS REPLACED THIS IPL TREATMENT HEAD UNDER WARRANTY. LUMENIS TECHNICAL SUPPORT TESTED THE IPL TREATMENT HEAD ON RECEIPT FROM THE CUSTOMER AND FOUND IT WITHIN SPEC. THE MOST LIKELY ROOT CAUSE APPEARS TO BE THAT THE TREATMENT HEAD HAD AN INTERMITTENT PROBLEM THAT WAS NOT OBSERVED BY LUMENIS TECHNICAL SUPPORT BECAUSE THE PROBLEM WAS JUST DEVELOPING. WITHOUT THE ADD'L DETAILS REQUESTED FROM THE CUSTOMER, NO FURTHER CONCLUSION CAN BE DRAWN REGARDING ROOT CAUSE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED COMPLAINT OF THE SYSTEM RUNNING HOT IN THE PAST SEVERAL WEEKS AND INJURING SEVERAL PTS IN ASSOCIATION WITH IPL TREATMENTS. THE CUSTOMER DID NOT PROVIDE SPECIFIC INCIDENT DATES OR PT/INCIDENT DETAILS, INCLUDING ANY MEDICAL INTERVENTION, ALTHOUGH LUMENIS REQUESTED THESE DETAILS.

    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 YR Other REQUESTED AND NOT PROVIDED.