BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER SC

    MDR report key: 1001406 · Received February 21, 2008

    Report

    Report Number
    2914019-2008-00007
    Event Type
    Other
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 21, 2008
    Manufacturer
    RH-USA
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEPOT CLEANED AND REMOVED SPOTS FROM TIP. CLEANED THE TOUCHSCREEN. PERFORMED ALL NECESSARY RELIABILITY CHECKS AND FINAL TEST. CUSTOMER WAS RE-EDUCATED REGARDING PROPER SYSTEM CLEANING AND MAINTENANCE AS PER PRODUCT LABELING.

    Description of Event or Problem · 1

    DIRTY TIP. IT WAS REPORTED BY THE LUMENIS ENGINEER THAT 2 PTS HAD DEVELOPED BLISTERS AFTER TREATMENT USING A LIGHTSHEER. THE USER FACILITY LATER STATED THAT THERE WERE NO INJURIES, JUST A LITTLE REDNESS. INSPECTION OF THE DEVICE WHEN IT ARRIVED AT DEPOT NOTED SPOTS INSIDE THE SAPPHIRE TIP AND A DIRTY TOUCHSCREEN. AN MDR IS BEING FILED FOR DIRTY TIP AS REQUESTED BY THE AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SC SOLID STATE AESTHETIC LASER GEX RH-USA LIGHTSHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other