BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 842104 · Received April 25, 2007

    Report

    Report Number
    2914019-2007-00013
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    March 23, 2007
    Report Date
    April 25, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER ROOT CAUSE OF THE INCIDENT APPEARS TO HAVE BEEN DEVICE OUTPUT FROM THE SR HEAD THAT WAS ELEVATED ( OUT OF SPECIFICATION). PER THE LUMENIS CUSTOMER ENGINEER CE, THE IPL CALIBRATION ADAPTOR FOR THE USER'S POWER METER WAS DAMAGED. THE GLASS WINDOW WAS SCARRED, WHICH WOULD CAUSE THE IPL TREATMENT HEAD TO CALIBRATE TOO HIGH DUE TO POOR LIGHT TRANSMISSION TO THE POWER METER. DAMAGE APPEARS TO BE 2 CIRCULAR BURNS 135 DEGREES APART, WHICH SCARRED ABOUT 1/3 OF THE TOTAL SURFACE AREA OF THE WINDOW. WHEN THE DEVICE OPERATOR CALIBRATED THE SR TREATMENT HEAD THROUGH THE DAMAGED POWER METER GLASS, A HIGH CALIBRATION OCCURRED. THE CE REPLACED THE ENTIRE POWER METER ASSEMBLY, SYSTEM RETURNED TO NORMAL AFTER RECALIBRATING FOR IPL OPERATION. SYSTEM PASSED OPERATIONAL AND SAFETY CHECKS. DURING INVESTIGATION WITH THE CUSTOMER, NO CAUSE (SUCH AS FOREIGN MATERIAL ON THE ENERGY METER GLASS) COULD BE ESTABLISHED FOR THE DAMAGE TO THE ENERGY METER GLASS. PER THE CUSTOMER, THE DEVICE WAS FREE OF DEBRIS AT THE TIME OF CALIBRATION. CUSTOMER WAS RECOMMENDED TO PERFORM A VISUAL INSPECTION OF THE ENERGY METER GLASS PRIOR TO EACH CALIBRATION AND - IF ANY CHANGE IN APPEARANCE OR DAMAGE TO THE GLASS ARE NOTED - TO SUSPEND USE OF THE DEVICE AND CALL LUMENIS SERVICE FOR EVALUATION.

    Description of Event or Problem · 1

    PER THE CUSTOMER, A PATIENT WAS BURNED IN ASSOCIATION WITH IPL HAIR REMOVAL TREATMENT TO THE RIGHT SIDE OF THE FACE. PER THE CUSTOMER, THE INCIDENT OCCURRED IN 2007. THE STAFF AESTHETICIAN LATER TESTED THE DEVICE ON HERSELF AND ALSO WAS BURNED. THE INCIDENT WAS REPORTED TO THE LUMENIS CE DURING A PERIOIDIC MAINTENANCE (PM) SERVICE VISIT. SERVICE ANALYSIS OF THE SAFETY COMPLAINT WAS PERFORMED DURING THE PM CALL WHILE THE CE WAS ONSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) OTHER GEX LUMENIS, LTD. QUANTUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR