BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 834993 · Received April 3, 2007

    Report

    Report Number
    2914019-2007-00010
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    January 29, 2007
    Report Date
    April 3, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATMENT PARAMETERS REPORTED BY THE CUSTOMER WERE CONSISTENT WITH THE LUMENIS PHYSICIAN RECOMMENDED FLUENCES FOR THE REPORTED SKIN TYPES. THE LIGHTSHEER DEVICE WAS EVALUATED BY LUMENIS SERVICE. THE SERVICE REPORT DESCRIBED TWO PROBLEMS THAT CAN CAUSE OR CONTRIBUTE TO BURNS: SPOTS ON THE SAPPHIRE TIP AND A KINKED UMBILICAL WHICH WAS ASSOCIATED WITH LOW COOLANT FLOW FROM THE HANDPIECE PUMP. THESE PROBLEMS APPEAR TO BE THE ROOT CAUSE OF THE INCIDENT. THE SERVICE DEPOT CLEANED THE SAPPHIRE TIP THOROUGHLY AND REPLACED THE UMBILICAL ASSEMBLY. OTHER REPAIRS NOT RELATED TO THE SAFETY COMPLAINT WERE PERFORMED AS INDICATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IN 2007 THAT CHILL TIP WAS BECOMING HOT (NO INJURIES REPORTED). CUSTOMER REQUESTED LOANER WHICH WAS PROVIDED, BUT CUSTOMER DEVICE WAS NOT RECEIVED AT SERVICE DEPOT UNTIL 03/06/2007. CUSTOMER REPORTED THE SAFETY COMPLAINT (2 PT'S BURNED OR BLISTERED) THE SAME DAY. MDR REPORTABLE DUE TO MEDICAL INTERVENTION INFO PROVIDED ON THE SAME DAY (ORAL STEROID- PREDNISONE AND/OR MEDROL- WAS PRESCRIBED FOR PT 1). AS OF THAT SAME DAY, CUSTOMER REPORTED THAT THE BURNS WERE RESOLVING WITH SCABBING; PT 1 ALSO HAD 3 SPOTS OF HYPERPIGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) OTHER GEX LUMENIS, INC. LIGHTSHEER ET *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention NONE REPORTED
    2 34 YR Required Intervention