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	Device Handling Problem (3265)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	02/15/2024
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.Customer reported that after using the 20mm tip for treatment it makes an abnormal.Also after their patients (four) treatment they notice a burning sensation of treatment area.They also asked to have the tips replaced, size 5, 18 & 20mm.No error codes/messages.System user also stated that she uses another spx at a different site and it does not make this noise.Service engineer visited the facility following (b)(4) and tested the device.He advised: "could not confirm customer complaint.Verified alignment ok.Verified all power outputs within manufacturers specifications however found alex on the high side of acceptable range.Found 18x18 and 20x20 tips protective lens burnt.Removed and replaced protective lens.Removed and replaced dirty vacuum filter.Unit is ready to use and released to (b)(6)." according to the provided information there is no device malfunction found, but poor condition of the device or its component caused by user error based on inappropriate handling and/or and lack of timely maintenance and therefore can be a possible reason for ae.Since no essential information was received 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.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 4 patients who sustained injury following treatment by spx device.Since the customer didn't provide even one incident form, these cases were treated in one single complaint.

• 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: 18901503
• Report Number: 3020611964-2024-00001
• Device Sequence Number: 9050512
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/14/2024
• Report Date (Section F): 03/14/2024

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: 02/15/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• 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: 03/14/2024