MAUDE Adverse Event Report: BIOS SPLENDOR X ALEX + ND:YAG; FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG),PRODUCT CODE: GEX

Model Number	SPLENDOR X ALEX + ND:YAG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	10/13/2023
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, patient photo.Service engineer tested the device and advised: "10/16 verified power calibration for alex and yag wavelengths, cleaned focus tip optics, found damaged cooling line from the zimmer to the hp.Ordered new cooling line.10/17 replaced the cooling line connecting the zimmer chiller to the hand piece.System meets specifications and is ready for use." manufacturer representative advised: "in my opinion this malfunction cannot lead to serious injuries.When the shots become "hot", well before developing serious burns, a rational and conscious patient asks to stop the treatment.In order the incident to become serious, the patient should withstand repeated shots on the same spot, willingly ignoring pain.So i would rate this event non-reportable." however, since the customer didn't provide us clinical data, this case will be submitted to the fda clinically wise in an 'abundance of caution'.Since no essential information was received within period which is determined for reportability, lumenis is reporting this 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.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 ALEX + ND:YAG
• Common Device Name: FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG),PRODUCT CODE: GEX
• Manufacturer (Section D): BIOS; s.r.l. via guido rossa 10/12; vimodrone (mi) 20090, it, 20090 ; IT 20090
• MDR Report Key: 18099415
• Report Number: 3020611964-2023-00015
• Device Sequence Number: 7717537
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 11/09/2023
• Report Date (Section F): 11/09/2023

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 ALEX + ND:YAG
• Device Catalogue Number: GA-5000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2023
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Date Report Sent to FDA: 11/09/2023