BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 22165772 · Received June 9, 2025

    Report

    Report Number
    3020611964-2025-00004
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 25, 2025
    Report Date
    June 8, 2025
    Manufacturer
    BIOS SRL
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    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 AND PATIENT PHOTO. INCIDENT FORM AND PATIENT PHOTOS HAVE BEEN RECEIVED IN LUMENIS. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER. SERVICE ENGINEER HAS CONCLUDED: "THE CUSTOMER EXPRESSED CONCERNS REGARDING THE ND YAG TREATMENT FOR TELANGIECTASIAS AND VASCULAR LESIONS ON THE FACE, SPECIFICALLY IN RELATION TO SKIN TYPE II. ALL OTHER TREATMENT SETTINGS WERE REPORTED TO BE SATISFACTORY. AN EVALUATION WAS CONDUCTED, RESULTING IN A DECISION TO ADJUST THE BASELINE SETTINGS FOR THE ND YAG VASCULAR TREATMENT TO THE MIDDLE OF THE SPECTRUM. ADDITIONALLY, THE CUSTOMER ADVISED ADOPTING A MORE CONSERVATIVE APPROACH FOR SKIN TYPE II PATIENTS, PARTICULARLY FOR THOSE PRACTITIONERS WHO MAY LACK EXPERIENCE WITH THIS SKIN TYPE. THE SYSTEM'S AVAILABILITY FOR SERVICE WAS LIMITED DUE TO FULL-DAY BOOKINGS WITH CLIENTS. OVERALL, THE CUSTOMER EXPRESSED SATISFACTION WITH THE CURRENT CONDITION OF THE SYSTEM." MORE PRECISELY AND BASED ON THE SERVICE MEASURING REPORT (ATTACHED IN 'NOTES & ATTACHMENTS' SECTION), THE BASELINE SETTINGS WERE STILL IN RANGE WITHIN THE UPPER ALLOWABLE LIMIT BEFORE THE ADJUSTMENT. HENCE, NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. THE DEVICE WAS INSTALLED ON (B)(6) 2025 AND STILL UNDER WARRANTY. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. A LUMENIS CLINICAL HEALTHCARE DIRECTOR CONCLUDED: "LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X SYSTEM. PATIENT BF IS A 65YO FEMALE LISTED AS FITZPATRICK II. SHE WAS TREATED FOR IPL RESISTANT FACIAL TELANGIECTASIA ON THE RIGHT MEDIAL CHEEK. THIS WAS THIS PATIENT'S FIRST TREATMENT ON THE SPLENDOR X. A PATCH TEST WAS NOT DONE, AND PRESETS WERE USED. THE PATIENT DENIED UV EXPOSURE AND IS REPORTED TO NOT HAVE ANY CONTRAINDICATIONS TO TREATMENT AND IS NOT TAKING ANY MEDICATIONS. THE TREATMENT SETTINGS ARE AS FOLLOWS: 5MM SPOT SIZE, 25MS PD, FLUENCE 110J, COOLING ON (NOT SPECIFIED WHAT LEVEL). IMMEDIATELY POST PULSE, THE LASER TECHNICIAN NOTED INAPPROPRIATE BLANCHING OF TISSUE AND APPLIED ICE. AN INJURY PHOTO IS NOT PROVIDED, BUT A PRETREATMENT AND HEALED INJURY PHOTO ARE PROVIDED. THE PHYSICIAN PRESCRIBED POLYSPORIN ANTIBIOTIC OINTMENT FOR THE REPORTED BLISTER. THE HEALED INJURY PHOTO SHOWS A DEPRESSED SCAR. THE PHYSICIAN NOTED THAT HER VERY EXPERIENCED LASER TECHS STATED THE SPLENDOR X "RUNS HOT". CM DONE BY A LUMENIS CERTIFIED ENGINEER SHOWS THE DEVICE IS OPERATING WITHIN SPECS. THE ROOT CAUSE IS USER ERROR. THE TELANGIECTASIA SHOWN IN THE PRE TREATMENT PHOTO SHOW VESSELS <0.5MM IN DIAMETER WITH A CENTRAL CLUSTER (POSSIBLE SPIDER ANGIOMA), SO A SMALLER SPOT SIZE WOULD HAVE BEEN MORE INAPPROPRIATE. THE LASER OPERATOR DID THE CORRECT PROTOCOL OF IDENTIFYING IMMEDIATELY AN INAPPROPRIATE TISSUE RESPONSE, PAUSING TREATMENT, AND APPLYING ICE. POSSIBLE EFFECTS: PERMANENT DEPRESSED SCARRING OF THE RIGHT MEDIAL CHEEK. THIS PATIENT MAY BENEFIT FROM RESURFACING TREATMENTS AND/OR DERMAL FILLERS." THE HAZARD SEVERITY WAS RATED BY CLINICAL DIRECTOR AS 8 OUT OF 10 - PERMANENT INJURY WITH NO IMPAIRMENT. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION FOUND. REGARDING THE CLINICAL EVALUATION THERE WAS A USER ERROR. THE TELANGIECTASIA SHOWN IN THE PRE TREATMENT PHOTO SHOW VESSELS <0.5MM IN DIAMETER WITH A CENTRAL CLUSTER (POSSIBLE SPIDER ANGIOMA), SO A SMALLER SPOT SIZE WOULD HAVE BEEN MORE INAPPROPRIATE. THE LASER OPERATOR DID THE CORRECT PROTOCOL OF IDENTIFYING IMMEDIATELY AN INAPPROPRIATE TISSUE RESPONSE, PAUSING TREATMENT, AND APPLYING ICE. FINALLY THE HAZARD SEVERITY WAS RATED AS SERIOUS INJURY. THEREFORE THIS CASE WAS DETERMINED AS REPORTABLE TO THE FDA. PER THE CANADIAN DECISION TREE, THIS CASE IS NOT REPORTABLE TO CMDR IN CANADA. A FEEDBACK LETTER HAS BEEN SENT TO THE CUSTOMER EXPLAINING HOW TO AVOID SUCH ISSUES IN THE FUTURE. SEE ATTACHED. LUMENIS IS NOT THE MANUFACTURER OF THE SPLENDOR X DEVICE, WHICH WAS USED DURING THIS PROCEDURE, LUMENIS HAS FORWARDED THE INFORMATION OF THIS EVENT TO THE LEGAL MANUFACTURER AND IS CLOSING THIS COMPLAINT.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BLISTER AND SCAR AT THE FACE AREA FOLLOWING TREATMENT BY SPLENDOR X DEVICE. TWO INCIDENT FORMS HAVE BEEN RECEIVED IN LUMENIS. THIS COMPLAINT WILL HANDLE PATIENT 2 OUT OF 2 WITH INITIALS - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401679 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS SRL SPLENDOR X 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other