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	05/01/2025
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, patient photo.The device is splendor ga-5000000: (b)(6).It's billable and being serviced by the distributor.They advised that they checked the output power and its in normal range, checked the earthing and it is normal as well.Then they checked all tips and lenses to be sure all clean.Device malfunction wasn't the suspected cause of the adverse event.According to the clinical expert, this complaint shows 4 different injured patients and therefore, this case will be cloned 3 times and each injured patient will be evaluated separately.This complaint is for patient 3 out of 4."pt #3: darker skin (likely fitz v) on unknown area with a relatively well demarcated patch of severe hyperpigmentation.Severity 5 or 8, pt will have lasting and possible permanent hyperpigmentation." based on the provided data, there is no conclusive evidence that the injury was caused by a malfunction of the device or its components.However, a partial clinical evaluation indicates that the injury maybe potentially serious, depending on further developing.Therefore, lumenis is reporting this event to the fda because of the severity of the injury as an importer.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.Nevertheless, due to the lack of information, it is not possible to establish a root cause for the adverse event (ae) or define user error.Therefore, no feedback letter is needed.Since lumenis is not the legal manufacturer of the device, this case is non-reportable by lumenis.Nevertheless, all the information of this adverse event was sent to the legal manufacturer "bios".
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by spx 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: 22164988
• Report Number: 3020611964-2025-00002
• Device Sequence Number: 7818728
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/08/2025
• Report Date (Section F): 05/28/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2025
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 06/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• 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: Unknown
• Date Report Sent to FDA: 05/28/2025