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	Missing Information (4053)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	07/08/2024
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.Reported that after treatment, their patient has severe burns.The customer asked for clinical support to help advise them and the patient for wound care.Later, clinical expert contacted customer and provided care and usage suggestions via email (see attached).The device ga-5000000: (b)(6) was installed in the facility on 6/24/2022 and the most recent pm was done on 4/25/2024.Since this customer is billable, they were advised for service but didn't accept to pay for it.Nevertheless, there is no allegation of malfunction.Since lumenis has yet to receive from the customer the completed incident form which would allow for a full clinical evaluation of the event within period, which is determined for reportability, lumenis is reporting this event to the fda 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.
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: 19904004
• Report Number: 3020611964-2024-00002
• Device Sequence Number: 17908664
• 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
• Type of Report: Initial
• Report Date (Section B): 08/05/2024
• Report Date (Section F): 08/05/2024

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: 07/08/2024
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• 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: 08/05/2024