BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 840103 · Received April 4, 2007

    Report

    Report Number
    2914019-2007-00011
    Event Type
    Other
    Date Received
    April 4, 2007
    Date of Event
    March 8, 2007
    Report Date
    April 4, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHTSHEER DEVICE WAS EVALUATED BY LUMENIS SERVICE. PER THE SERVICE REPORT, THERE WAS GEL RESIDUE ON THE TOUCHSCREEN WHEN THE DEVICE WAS RECEIVED AT THE SERVICE DEPOT. GEL ON THE TOUCHSCREEN CAN CAUSE SCROLLING FLUENCE; HOWEVER, THE CUSTOMER DID NOT REPORT A SCROLLING FLUENCE PROBLEM. ALSO PER THE SERVICE REPORT, ENERGY METER GLASS WAS CLEAN. SAPPHIRE TIP APPEARANCE WAS GOOD (NO FOREIGN MATERIAL NOTED). COMPLETED INITIAL FINAL TO VERIFY ENERGY OUTPUTS. CLEANED TOUCHSCREEN. PERFORMED ENERGY METER CALIBRATION. PERFORMED ALL NECESSARY RELIABILITY IMPROVEMENTS AND FINAL TEST. PER THE LUMENIS INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT IS NOT RELATED TO THE LIGHTSHEER DEVICE. PER THE PHYSICIAN, THREE PTS HAD COMPLAINED OF SWELLING AND PAIN AFTER LIGHTSHEER TREATMENT AND TWO OF THE PTS WERE PRESCRIBED STEROID MEDICATION. ALL OF THE PTS HAD UNDERGONE MULTIPLE PRIOR LIGHTSHEER TREATMENTS WITHOUT PAIN OR SWELLING. IN A FOLLOW-UP CONTACT IN 2007, DR STATED THAT ONLY 2 PTS WERE ASSOCIATED WITH THIS INCIDENT. THE PHYSICIAN ASSISTANT CALLED THE FOLLOWING DAY TO PROVIDE THE NAMES OF THE MEDICATIONS PRESCRIBED. PER THE FOLLOW-UP CONTACTS ON THE ORIGINAL DAY AND THE FOLLOWING DAY, ALL OF THE PTS ARE NOW FINE. WITHOUT THE PT SKIN TYPES, LUMENIS IS UNABLE TO EVALUATE THE TREATMENT PARAMETERS PROVIDED BY THE CUSTOMER. ADDITIONAL REQUEST FOR THE SKIN TYPES WAS MADE BY LUMENIS ON THAT DAY. BASED ON THE DETAILS AVAILABLE AS OF THE SAME DAY, NO ROOT CAUSE COULD BE DETERMINED FOR THE INCIDENT.

    Description of Event or Problem · 1

    PHYSICIAN STATED SHE WAS CONCERNED ABOUT POSSIBLE CALIBRATION ISSUES WITH HER LIGHTSHEER DEVICE. PER THE PHYSICIAN, THREE PTS HAD COMPLAINED OF SWELLING AND PAIN AFTER LIGHTSHEER TREATMENT AND TWO OF THE PTS HAS BEEN PRESCRIBED STEROID MEDICATION. PER THE PHYSICIAN, ALL OF THE PTS HAD UNDERGONE MULTIPLE PRIOR LIGHTSHEER TREATMENTS WITHOUT PAIN OR SWELLING. IN A FOLLOW-UP CONTACT IN 2007, DR STATED THAT ONLY 2 PTS WERE ASSOCIATED WITH THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NONE REPORTED
    2 * Required Intervention