MAUDE Adverse Event Report: BIOS S.R.L. SPLENDOR X; SPLENDOR X ALEX+ND:YAG

Model Number	SPLENDOR X 1.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following information comes from lumenis, the bios importer/distributor: 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 (b)(6)) 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.Bios confirmed to report this event also as manufacturer and 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.
Event or Problem Description
Lumenis, the bios s.R.L.Distributor, received an adverse event report on a patient who sustained injury following treatment by spx device.

• Brand Name: SPLENDOR X
• Common Device Name: SPLENDOR X ALEX+ND:YAG
• Manufacturer (Section D): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer (Section G): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer Contact: edoardo tronchet ; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• MDR Report Key: 22209497
• Report Number: 1720381-2025-00003
• Device Sequence Number: 8620505
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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 1.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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