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 Code	Burn(s) (1757)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by spx device.
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 customer reported on injury of patient's skin following treatment on face area.The device ga-5000000: (b)(6) was installed in the facility on 6/14/2024 and it's on warranty.There is no allegation of malfunction.Regional clinical expert reviewed the data and advised: lumenis received notification of an adverse event involving the splendor x using the rosacea preset settings as follows: 5mm spot size, 25ms pd, fluence not listed, hz not listed, 4+ passes done, zimmer cooling not used for the first cheek.Test patch was not performed, consent was signed and the patient denied contraindications to laser treatment.Photos provided by the customer shows a fitzpatrick iii (possibly iv- her ethnicity is not listed) with marked edema, erythema, and yellow, fluid filled bullae over the bilateral lower third of the cheeks to the jawline.The patient's left lower face is more severely affected.Possible effects: prolonged dermatological care with prescriptive oral and topical medications, possible reconstructive procedures, possible long term pigmentary changes.Investigation conclusions: user error.The zimmer chiller was not used on one side of the face, a test patch and pause were not done per ifu, tissue response was not properly evaluated, an inappropriate number of passes were used over a large surface area of the face.The severity is 6-8 with second-third degree burns in a high profile area.It is possible that this patient will require reconstructive procedures and may have permanent injury without impairment." since severity of the injury is high rated 8 out of 10, lumenis is reporting this case the fda 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.

• 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: 19989743
• Report Number: 3020611964-2024-00003
• Device Sequence Number: 15204005
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/15/2024
• Report Date (Section F): 08/15/2024

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: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 08/15/2024