BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 6405329 · Received March 15, 2017

    Report

    Report Number
    3004135191-2017-00031
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 16, 2017
    Report Date
    July 15, 2018
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION JUL 15 2018. NO TREATMENT SETTINGS OR PATIENT PHOTOGRAPHS WERE PROVIDED BY THE USER FACILITY; THEREFORE, A CLINICAL REVIEW OF TREATMENT SETTINGS CANNOT BE PERFORMED. A LUMENIS QUALITY ASSURANCE ENGINEER REVIEWED THE REPORTED EVENT AND CONCLUDED BY NOTING THE FOLLOWING: REVIEW OF PRODUCT DHR SHOWED IT WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE ACCORDING TO SPECIFICATIONS. 1. THE ET HANDPIECE WAS SENT TO LUMENIS LTD. FOR INVESTIGATION, BUT UNFORTUNATELY WAS LOST DURING TRANSIT. 2. FIELD ENGINEER COULD NOT DUPLICATE EVENT WITH ET HP AND NO SIMILAR EVENTS REPORTED IN THE PAST. 3. POWER METER PROTECTIVE GLASS WAS CHIPPED AND REPLACED. A REVIEW OF DEVICE LABELING UM-1080310 STATES THE FOLLOWING: WARNING - THE INTERNAL POWER METER WINDOW MUST BE CLEAN TO ENSURE ACCURATE CALIBRATION. AN UNCLEAN WINDOW AND/OR HANDPIECE'S SAPPHIRE TIP OR INSERT WILL RESULT IN HIGHER THAN INDICATED FLUENCE, WHICH MAY CAUSE EPIDERMAL DAMAGE. A REVIEW OF LIGHTSHEER DUET HS/ET PRODUCT RISK FILE SHOWS THIS IS AN ANTICIPATED RISKS (14.1.1.1 IN RISK FILE RD-1084050_L) WHICH HAS BEEN QUANTIFIED AND FOUND TO UNLIKELY TO LEAD TO A SERIOUS INJURY IF MALFUNCTION WERE TO RECUR. THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT. THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED. FURTHER REVIEW OF COMPLAINT TRENDING FOR THE PERIOD OF MARCH 2015 TO MARCH 2017 REVEALED THAT THE ISSUE OF DAMAGED POWER METER WINDOW HAD NOT TRIGGERED ANY ACTION LIMIT, THUS NOT REQUIRING ANY CAPA. WITH REGARDS TO THE MISSING GROUND PIN IN THE POWER CABLE: THE THIS IS UNLIKELY TO LEAD TO THE DESCRIBED PHENOMENA OR CONTRIBUTE TO BURNING SMELL OR FROZEN SCREEN AS DESCRIBED BY THE USER. THERE ARE NO SIMILAR DOCUMENTED EVENTS THAT WOULD SUPPORT A CORRELATION BETWEEN THE FACTS. SYSTEMS ARE SHIPPED WITH THE GROUNDED CABLE, AND IT IS UNCLEAR HOW IT CAME TO BE THAT A CABLE MISSING THE GROUND PIN WAS FOUND INSTEAD. THE PROBABLE CAUSE OF THE REPORTED EVENT TO BE OPERATOR ERROR, A FAILURE ON THE PART OF THE DEVICE OPERATOR TO FOLLOW USER MAINTENANCE AS DESCRIBED IN THE DEVICE LABELING. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY OCCURRED, BECAUSE OF THE LACK OF INFORMATION THE COMPANY IS REPORTING THE EVENT IN AN ABUNDANCE OF CAUTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. REASONABLE ATTEMPTS WERE MADE BY PHONE (3X) AND EMAIL (2X) TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, AND SUN EXPOSURE. NO INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING CALIBRATION, AND OUTPUT POWER OF BOTH HS AND ET HANDPIECES, THE SUBJECT DEVICE OPERATED WELL WITHIN MANUFACTURE SPECIFICATIONS. ADDITIONALLY, THE TECHNICAL EXPERT NOTED THAT THE REPORTED ET HANDPIECE DISCHARGING ENERGY ON ITS OWN COULD NOT BE DUPLICATED. THE ET HANDPIECE WAS REPLACED AND THE HANDPIECE IN QUESTION IS BEING SENT BACK TO THE MANUFACTURE FOR FURTHER INVESTIGATION AND ANALYSIS. LUMENIS IS CONTINUING ITS INVESTIGATION. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO THE BUTTOCKS AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER, ET HANDPIECE. IT WAS FURTHER REPORTED THAT THE ET HANDPIECE BEGAN TO DISCHARGE LASER ENERGY ON ITS OWN WHICH IS WHAT CAUSED THE BURN ON THE PATIENT. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL COMPLAINT FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189497 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other