MAUDE Adverse Event Report: BIOS SRL SPLENDOR X; FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)

Model Number	SPLENDOR X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by spx device.
Additional Manufacturer Narrative
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 customer reported on adverse reaction right side of the nose during spider vein treatment.Yag vascular - mild redness.The device ga-5000000: (b)(6) was installed at the facility on (b)(6) 2022, and the most recent pm was done on 2/12/2025.This device is under contract.The service engineer tested this device and advised: "9/30/2025 initial system start and inspection shows normal function.Output power calibration check at all output powers on checklist.Tip recognition of all tips.This system performs to all lumenis standards and specifications as described in the lumenis service checklist.Nff." device malfunction wasn't the suspected cause of the adverse event.Regional clinical and training expert has reviewed the clinical data and advised as follows: "lumenis received a report of an adverse event involving the splendor x device on the vascular lesion modality.The injured patient is reported as a 40yo female, fitz iii-iv.Photos included show a patient with more olive-toned skin indicating possible fitz iv.Ethnicity is not listed.The patient denied contraindications and had one treatment prior without sequelae (done 4 weeks prior to this event).Photos and narrative show frosting and crusting of the right nasal ala.The left ala was treated also without sequelae.Settings used are reported as 5mm spot size, 110j, 20ms pd, cooling on (unspecified at what level).Two weeks post treatment the patient was noted to have pih and cratered scarring on the right nasal ala.Post treatment the patient was recommended topical antibiotic ointment and once hyperpigmentation was identified, topical bleaching."user error.Treatments were done too close together (4 weeks).The photographs provided show small diameter, superficial telangiectasia, the 5mm spot size with 20ms pd was likely too large for the profile of the lesions.This patient has a darker skin type, conservative settings and patch testing should always be practiced with fitzpatrick iv-vi.It is unspecified what level the zimmer chiller was at, but if careful pre and post cooling are not practiced, an event could occur.Possible effects: temporary hyperpigmentation.Scarring requiring further procedures.8 - permanent injury with no impairment." since the injury is serious rated 8, this case is defined as reportable to the fda by lumenis due to serious injury.An adverse event caused by user error.Nevertheless, no fail was found during testing of the device.Lumenis sent all available information to the legal manufacturer of the device 'bios'.

• Brand Name: SPLENDOR X
• Common Device Name: FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)
• Manufacturer (Section D): BIOS SRL; via guido rossa, 10/12; vimodrone, ita 20090 ; IT 20090
• MDR Report Key: 23356456
• Report Number: 3020611964-2025-00011
• Device Sequence Number: 13003134
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025
• Report Date (Section F): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: SPLENDOR X
• Device Catalogue Number: GA-5000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2025
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female