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	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/19/2025
Type of Reportable Event	Serious Injury
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 and patient photo.Since the customer sent us 2 incident forms, each case will be treated separately.This complaint is for patient cristal.The device ga-5000002us:spxay20-25c-00046 was installed on (b)(6) 2025, and still under warranty.The service engineer visited the facility and performed energy checks for safety case.All energy was within range and machine is working properly.Nff.Device malfunction wasn't the suspected cause of the adverse event.The regional clinical expert evaluated this ae based on the provided data and advised as follows: "lumenis received a report of an adverse event involving the splendor x.The injured patient is reported as a 40yo female, listed as fitzpatrick iv.Photos show medium-toned african american skin.This was this patient's first treatment.Settings are recorded as 18mm spot, bled alexandrite 5j yag 6j, pd not listed, cooling on (unspecified level), 2hz."immediately post treatment, the patient complained of pain, dizziness, darkening squares on the treated areas.24 hours post, the patient is reported to using hydrinity restorative serum and hyacin spray.48 hours post treatment the patient noted blistering and sought emergency room care.She was diagnosed with second degree burns.Photos demonstrate pih and compromised tissue on the bilateral full legs.9 - permanent injury resulting in permanent impairment."root cause failure: user error.No test patch was done.Inappropriate total fluence and alexandrite fluence for skin type.Failure to recognize unsatisfactory tissue response.Misdiagnosis of skin type and ethnicity.Possible effects: prolonged pih and hypopigmentation.Scarring and permanent pigment changes are possible." since the injury is serious (rated 9 out of 10), lumenis is reporting this case to the fda as an importer.Lumenis has sent all the information to the legal manufacturer of the device "bios".
Event or Problem Description
Lumenis received an adverse event report on patient who sustained burn at the axilla area following treatment by splendor x 2.0 device.

• 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: 23473734
• Report Number: 3020611964-2025-00012
• Device Sequence Number: 10488103
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/05/2025
• Report Date (Section F): 11/05/2025

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-5000002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2025
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• 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
• Date Report Sent to FDA: 11/05/2025