BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2511477 · Received March 30, 2012

    Report

    Report Number
    3004135191-2012-00015
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 30, 2012
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE AND DEVICE LABELING. AN EXAMINATION OF THE SUBJECT DEVICE BY LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THE DEVICE OPERATED WITHIN MANUFACTURER SPECIFICATIONS. A REVIEW OF SUBJECT DEVICE OPERATOR MANUAL FOUND THAT THE MANUAL CLEARLY DESCRIBES THE STEPS THAT SHOULD BE TAKEN IF THE REPORTED UNRESPONSIVE STATE OF THE DEVICE WERE TO OCCUR. ADDITIONALLY, A LUMENIS TRAINING EXPERT CONFIRMED THAT DEVICE OPERATORS ARE TRAINED TO FOLLOW INSTRUCTIONS AS OUTLINED IN SUBJECT DEVICE LABELING: "WARNING - IMMEDIATELY CEASE USE OF THE LASER IF THE TOUCHSCREEN BECOMES UNRESPONSIVE, OR IF THE TRIGGER FAILS IN THE PRESSED STATE. DEACTIVATE THE LASER EITHER BY PRESSING THE EMERGENCY STOP BUTTON OR TURNING THE LASER KEYSWITCH TO THE OFF POSITION. AFTER WAITING ONE MINUTE, TURN THE KEYSWITCH TO THE ON POSITION. IF THE LASER REMAINS UNRESPONSIVE, DO NOT USE THE LASER; CONTACT YOUR LOCAL LUMENIS SERVICE REPRESENTATIVE." AN EXAMINATION OF ESTIMATES OF THE NUMBER OF TREATMENTS PERFORMED WITH THE SUBJECT DEVICE CONCLUDED THE POTENTIAL FOR RECURRENCE OF THE REPORTED EVENT IS EXTREMELY RARE AND HAS OCCURRED IN APPROXIMATELY (B)(6) OF TREATMENTS. LUMENIS CONCLUDES THE ROOT CAUSE OF THE EVENT REPORTED TO BE OPERATOR ERROR: FAILURE ON THE PART OF THE DEVICE OPERATOR TO FOLLOW INSTRUCTIONS AS DESCRIBED IN SUBJECT DEVICE LABELING TO CEASE USE OF THE DEVICE WHEN A FAULT STATE OCCURS AND RESTART THE SYSTEM PRIOR TO CONTINUING TREATMENT. AS A REMINDER TO DEVICE OPERATORS OF THE INFORMATION PRESENTED IN SUBJECT DEVICE LABELING, AN ADVISORY NOTICE WAS DISTRIBUTED TO LUMENIS CUSTOMERS OF RECORD. THE NOTICE ADVISES DEVICE OPERATORS TO CAREFULLY FOLLOW THE INSTRUCTIONS DESCRIBED IN SUBJECT DEVICE OPERATOR MANUAL SHOULD THE DEVICE PERFORM IN A SIMILAR UNANTICIPATED MANNER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SUPERFICIAL BURN TO THE UPPER LIP FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SUN EXPOSURE. IT WAS FURTHER REPORTED THAT THE DEVICE OPERATOR CONTINUED TO PERFORM TREATMENT ALTHOUGH UNABLE TO ADJUST THE SYSTEM SETTINGS DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS LTD LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other