BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER XC EXTENDED PULSE

    MDR report key: 801778 · Received January 3, 2007

    Report

    Report Number
    2914019-2005-00085
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    July 19, 2005
    Report Date
    January 3, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS SERVICE DEPOT, THE LIGHTSHEER LOANER HAD A LARGE SPOT ON THE SAPPHIRE TIP; DEVICE ENERGY WAS IN SPECIFICATION. THIS FOREIGN MATERIAL APPEARS TO BE THE ROOT CAUSE OF THE INCIDENT. THE CUSTOMER STATED THAT THEY NEVER PERFORM TEST SPOTS AND STATED THAT INSTEAD, THEY LOWER THEIR FLUENCES WITH LOANERS. LUMENIS RECOMMENDS TEST SPOTS. LUMENIS CAN NOT RULE OUT THE POSSIBILITY THAT THE FAILURE OF THE CUSTOMER TO PERFORM TEST SPOTS CONTRIBUTED TO THE PT BURNS REPORTED IN ASSOCIATION WITH THIS SAFETY COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THREE PTS WERE BURNED FOLLOWING TREATMENT WITH THEIR LIGHTSHEER LOANER UNIT THAT THEY REC'D YESTERDAY. CUSTOMER REPORTED THAT THEY DID NOT PERFORM TEST SPOTS WITH THE LUMENIS LOANER.

    Description of Event or Problem · 2

    CUSTOMER REPORTED THAT THREE PTS WERE BURNED FOLLOWING TREATMENT WITH THEIR LIGHTSHEER LOANER UNIT THAT THEY REC?D YESTERDAY. CUSTOMER REPORTED THAT THEY DID NOT PERFORM TEST SPOTS WITH THE LUMENIS LOANER.

    Description of Event or Problem · 3

    CUSTOMER REPORTED THAT THREE PTS WERE BURNED FOLLOWING TREATMENT WITH THEIR LIGHTSHEER LOANER UNIT THAT THEY REC'D YESTERDAY. CUSTOMER REPORTED THAT THEY DID NOT PERFORM TEST SPOTS WITH THE LUMENIS LOANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER XC EXTENDED PULSE LIGHTSHEER GEX LUMENIS, INC. 55-05350-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other NONE REPORTED.
    2 54 YR Other
    3 32 YR Other