BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X ALEX + ND:YAG

    MDR report key: 17849334 · Received October 1, 2023

    Report

    Report Number
    3020611964-2023-00014
    Event Type
    Injury
    Date Received
    October 1, 2023
    Date of Event
    September 4, 2023
    Report Date
    October 1, 2023
    Manufacturer
    BIOS
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE DISTRIBUTOR. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN, PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. DISTRIBUTOR REPORTED ON BEHALF OF CUSTOMER: "IN THE DOCTOR'S OPINION, THE STRUCTURE OF THIS MENU DOES NOT CORRESPOND TO THE LOGIC OF WORKING WITH BLOOD VESSELS. WITH THIS PATIENT, HE TRIED WORKING WITH DIFFERENT PRESET MODES. ALMOST EVERYWHERE THERE IS A LONGER PULSE (MORE THAN 10 MILLISECONDS) AND THIS MODE BURNS. IF HE WERE MAKING A MENU FOR THE DEVICE, HE WOULD SIMPLY BE BASED ON THE DIAMETER OF THE VESSELS, FOR EXAMPLE. OR THEN TAKE ALL THE MOST COMMON NOSOLOGY WITH LOCALIZATION (SINGLE CAPILLARY, MESH ON THE CHEEKS, SUPERFICIAL CAPILLARIES ON THE LEGS, PORT WINE, ROSACEA, VESSELS ON THE WING OF THE NOSE, SOMETHING LIKE THAT)." THE DEVICE GA-5000000:(B)(6) WAS INSTALLED IN THE FACILITY ON (B)(6) 2022. SINCE THIS DEVICE BELONGS TO THE DISTRIBUTOR UAB BIOMEDIKOS CENTRAS, THERE ARE NO INFORMATION AVAILABLE IN LUMENIS'S SERVICE HISTORY. HOWEVER, INITIATOR OF THE COMPLAINT CONTACTED CUSTOMER AND ADVISED: "DISTRIBUTOR CONFIRMED THERE WERE NO FAULTS. AND THEY SENT ME IN LAST EMAIL - THE LAST VISIT TO THE CONFIDO CLINIC WAS A HALF YEAR AGO. ALL PARAMETERS WERE WITHIN NORMAL LIMITS, INCLUDING ENERGY AS WELL." PROF. ED. & CLINICAL TRAINING DIRECTOR ADVISED: "A PICTURE OF A HIGHLY PURPURIC SKIN RESPONSE ON PWS POST LONG-PULSE ND;YAG WITH RESULTING CIRCUMSCRIBED PITTED SCARRING AT THE DENSEST VASCULAR AREAS WAS SENT. AS PER EVENT DESCRIPTION, THE PARAMETERS USED WERE EMBEDDED SYSTEM PRESETS (PWS IS NOT A STORED CONDITION THOUGH) BUT THE TECHNIQUE USED IS UNKNOWN. THE TOTAL ENERGY PROVIDED TO SOME DENSE AREAS WAS VERY LIKELY TOO HIGH. THE LONG-PULSE ND;YAG IS A CHALLENGING OPTION WHEN USED ON THE FACE AS IT DOES NOT TOLERATE EXCESSIVE FLUENCE LEVELS, ANY PULSE STACKING , INSUFFICIENT POST-OP COOLING. PARAMETERS USED ARE WITHIN MANUFACTURER'S GUIDELINES BUT HOW THEY GOT APPLIED ONTO THE CONDITION IS UNCLEAR. THE PATIENT SUSTAINED A SERIOUS INJURY LEADING TO A PERMANENT IMPAIRMENT IN THE FORM OF SCARRING AND THE HAZARD SEVERITY GOT RATED TO A 6 OUT OF 10; SERIOUS INJURY REQUIRING NON-SURGICAL MEDICAL TREATMENT". SINCE THE INJURY IS SERIOUS, THIS CASE IS DETERMINED AS REPORTABLE TO THE FDA BY LUMENIS AS AN IMPORTER OF THE DEVICE. AS FAR AS LUMENIS IS NOT THE LEGAL MANUFACTURER (LM) OF THE DEVICE, ALL THE INFORMATION OF THIS ADVERSE EVENT WAS SENT TO THE LM "BIOS" WITH REQUEST TO DECIDE ON REPORTABILITY BY THEM TO EU-MDR AND TO THE FDA AS A MANUFACTURER. LATER, THEY SUBMITTED THE MIR REPORT TO HEALTH BOARD, MEDICAL DEVICES DEPARTMENT.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276935 SPLENDOR X ALEX + ND:YAG FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG),PRODUCT CODE: GEX GEX BIOS SPLENDOR X ALEX + ND:YAG 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other