MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG ARVEO; SURGICAL MICROSCOPE

Model Number	10448999
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Event or Problem Description
Leica microsystems (schweiz) ag, received a complaint from usa related to an arveo stating that a pediatric patient was discovered to have a 2nd degree burn after surgery was completed.
Additional Manufacturer Narrative
This is a final report.An on-site investigation was performed on the actual device.The device performed as per specification, with no indication of malfunction.Tests were performed on a representative sample: · when "brightcare" is activated, the light intensity is automatically limited.· when shipped from the factory, the "brightcare" safety feature is activated in every arveo for all users.· when attempting to deactivate the "brightcare" function, a dialog window opens informing the user that "brightcare" is a safety feature that limits brightness at working distances which are too short and that bright light at short working distances may cause thermal injury to patients.The user must confirm the deactivation of the "brightcare" safety function.· to disable the "auto iris" feature the rotary button must be moved to increase or decrease the field of view.A review of the service and the device history records did not reveal any issue that could explain the complaint.A review of the complaint database, which found no similar or identical complaint, showed that the issue is an isolated incident.A review of the instructions for use showed that the warnings regarding the heat generated by the xenon light source and the resulting tissue heating are appropriate.In addition, the instructions for use clearly indicate how to properly adjust the light intensity.It is suspected that the injury was caused by incorrect use of the device, as the feedback received, and the data analyzed conclude that the device is working in accordance to its defined specification.Lt cannot be ruled out, that other circumstances or consumables/equipment used during surgery caused or contributed to the incident.The fse ensured that "brightcare" was activated in all user settings of all leica surgical operating microscopes in the hospital.In addition, users were informed on how to properly activate and deactivate "brigthcare".
Additional Manufacturer Narrative
Udi / gudid related data quality updates only.

• Brand Name: ARVEO
• Common Device Name: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• Manufacturer (Section G): LEICA INSTRUMENTS (SINGAPORE) PTE LTD; 12 teban gardens crescent; singapore, 60892 4; SN 608924
• Manufacturer Contact: manuel pfundstein ; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 18190835
• Report Number: 3003974370-2023-00032
• Device Sequence Number: 15119014
• Product Code: EPT
• UDI-Device Identifier: 07630003593280
• UDI-Public: (01)07630003593280(11)201216
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10448999
• Device Catalogue Number: 10449099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 06/25/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown