BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER QUATTRO

    MDR report key: 16642471 · Received March 30, 2023

    Report

    Report Number
    3021349626-2023-00006
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 30, 2023
    Manufacturer
    LUMENIS BE LTD.
    Product Code
    GEX
    UDI-DI
    07290109144658
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. THE DEVICE GA-1140000:LSQ00213 WAS INSTALLED IN THE FACILITY ON (B)(6) 2020 AND THE MOST RECENT PM WAS DONE ON (B)(6) 2022. SERVICE ENGINEER TESTED THE DEVICE AND ADVISED: "OBSERVED CUSTOMER REPORTED ISSUE, PATIENT GOT BURNT DURING TREATMENT. TALKED TO CX, AND ISSUE COULD HAVE OCCURRED DUE TO USE OF DIFFERENT SETTING THAN THAT PATIENT SKIN TYPE BUT FOR PRECAUTION REPLACED THE COOLANT, CHECKED THE COOL TIP TEMP WHICH IS IN RANGE AND CALIBRATED BOTH HANDPIECES. ISSUE RESOLVED. PREVENTATIVE MAINTENANCE PERFORMED PER LUMENIS SPECIFICATIONS. SOFTWARE-FIRMWARE IS THE NEWEST REVISION, 1.1.1.15. UNIT CALIBRATED, TESTED, AND OPERATIONAL; READY FOR CUSTOMER UTILIZATION." DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION. CLINICAL EVALUATION WASN'T PERFORMED IN 30 DAYS FRAME, THEREFORE LUMENIS IS REPORTING THE EVENT IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LSQ DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241282 LIGHTSHEER QUATTRO SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS BE LTD. LIGHTSHEER QUATTRO 07290109144658

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Other