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	10/31/2023
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.No incident form or patient photos have been received in lumenis.An examination of the subject device was performed by lumenis service engineer after verifying all system functions including cooling system verification.Verification of integrity and functionality of the optical fiber.Confirmation of alignment, focus, and centering.Checking safety, mechanical and interface functions.Confirmation of energy at various settings and ensuring proper delivery of energy out the handpieces.Spot size 20x20 has some pitting.The subject device operated well within lumenis specifications.No device malfunction was observed.The system was operational and was ready for use.The device was installed on march 03, 2023 and still under warranty.Device malfunction wasn't the suspected cause of the adverse event.Clinical evaluation wasn't performed, since no incident form or patient photos were sent to lumenis.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.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 blister following treatment by splendor x 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: 18207670
• Report Number: 3020611964-2023-00016
• Device Sequence Number: 12629255
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2023
• Report Date (Section F): 11/26/2023

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?: Yes
• Distributor Facility Aware Date: 11/01/2023
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2023
• 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: 11/26/2023