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 Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/18/2025
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.Incident form and patient photos have been received in lumenis.The device was installed on (b)(6) 2025 and still under warranty.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including output energy verification, found all power parameters in specification.No device malfunction was observed.The system was operational and was ready for use.Device malfunction wasn't the suspected cause of the adverse event.A lumenis clinical healthcare manager concluded: "lumenis received a report of an adverse event involving the splendor x for vascular treatment.The patient is a male fitzpatrick ii and the area treated was a large cluster of vascularity on the medial right lower leg.The settings are reported as lp yag, 5mm spot size, 100j, 30ms pd.It is reported that the zimmer chiller was not on during the first 2-3 pulses, and that is where the area of injury originated.The patient reported immediate discomfort.Photos demonstrate a well demarcated, deep area of scabbing and ulceration with surrounding erythema and edema.The patient is under the care of a dermatologist and is using topical healing ointment.This is user error, abundant external cooling is essential during vascular treatments.Photos show a dense area of vascularity in this area, the treatment approach should have been very cautious.Possible effects: scarring, infection." 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.User facility didn't use external cooling during the treatment.Abundant external cooling is essential during vascular treatments.Photos show a dense area of vascularity in this area, the treatment approach should have been very cautious.Finally the hazard severity was rated as serious injury.Therefore this case was determined as reportable to the fda.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.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury 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 20055 ; IT 20055
• MDR Report Key: 23677003
• Report Number: 3020611964-2025-00013
• Device Sequence Number: 8900956
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2025
• Report Date (Section F): 06/08/2025

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-5000002US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2025
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2025
• 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: Male
• Date Report Sent to FDA: 06/08/2025