BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS 1

    MDR report key: 823793 · Received February 21, 2007

    Report

    Report Number
    2914019-2006-00125
    Event Type
    Other
    Date Received
    February 21, 2007
    Date of Event
    November 18, 2006
    Report Date
    February 21, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LUMENIS CUSTOMER ENGINEER CE EVALUATED THE LUMENIS ONE DEVICE. PER THE CE, THE CUSTOMER HAD PLUGGED THE LUMENIS ONE DEVICE INTO A 15-AMP ELECTRICAL OUTLET INSTEAD OF THE RECOMMENDED 20-AMP SERVICE. IN ADDITION, THE CUSTOMER WAS USING A 3-FOOT EXTENSION TO CONNECT THE LUMENIS ONE DEVICE TO THE WALL OUTLET, WHICH IS NOT RECOMMENDED BY LUMENIS, PER THE CE, THE LIGHTSHEER SAPPHIRE TIP WAS CLEAN. THE CE RECOMMENDED INSTALLATION OF 20-AMP SERVICE AND REPLACEMENT OF THE LUMENISONE CORD. THE CUSTOMER DID UPGRADE THE ELECTRICAL SERVICE TO THE TREATMENT ROOM, AFTER WHICH THE LUMENIS CE INSTALLED A NEW POWER CORD ON THE LUMENIS ONE. FOLLOWING THESE STEPS, THE CE VERIFIED THAT THE LUMENIS ONE DEVICE WAS IN SPECIFICATION. THE REPORTED TREATMENT PARAMETERS WERE HIGHER THAN THE RECOMMENDED PARAMETERS FOR THE REPORTED SKIN TYPES: THIS APPEARS TO BE THE ROOT CAUSE OF THE INCIDENTS. LUMENIS RECOMMENDED THAT THE CUSTOMER OBTAIN ADDITIONAL TRAINING FROM LUMENIS. THE PHYSICIAN WAS ALSO REFERRED TO THE LUMENIS PHYSICIAN RECOMMENDED PARAMETERS, A COPY OF WHICH WAS PROVIDED TO THE PHYSICIAN BY LUMENIS.

    Description of Event or Problem · 1

    ON 11/20/2006, THE PHYSICIAN REPORTED THAT TWO PATIENT'S HAD BEEN BURNED. LUMENIS REQUESTED PATIENT AND INCIDENT DETAILS, WHICH WERE NOT PROVIDED BY THE CUSTOMER. THREE DAYS EARLIER, THE PHYSICIAN REPORTED THAT A TOTAL OF THREE PATIENT'S HAD BEEN BURNED AND THAT THE PATIENT'S HAD BEEN GIVEN PRESCRIPTION MEDICATION (HYDROCORTISONE 4% CREAM) FOR THE BURNS, TWO OF THE PATIENT'S HAD HEALED AND ONE PATIENT HAD MILD HYPOPIGMENTATION WHICH THE PHYSICIAN WAS FOLLOWING AND HAD TREATED WITH MICRODERMABRASION. THE COMPLAINT WAS DETERMINED TO BE MDR REPORTABLE BASED ON THIS NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS 1 COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER GEX LUMENIS, LTD. * *

    Patients

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