MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG ARVEO 8; SURGICAL MICROSCOPE

Model Number	10449063
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from china related to an arveo 8 stating that a patient was discovered to have a 2nd degree burn after surgery was completed.
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.
Additional Manufacturer Narrative
This is a final report.An on-site investigation of the actual device was conducted.The device performed as per specification, with no indication of malfunction.A review of the manufacturing instruction and the service history records revealed no issues that could explain the complaint.An assessment of the computer unit log file and the provided video data was performed.A review of brightcareplus report was performed.It was verified that the correct filters are installed on the actual device.A review of the user manual showed that the instructions are adequate.Based on the investigation results and the review of the complaint database, we conclude that it is unlikely that the device caused or contributed to the patient's skin burn.The cause of the reported injury remains unknown.Lt cannot be ruled out, that other circumstances (e.G.Patient characteristics regarding skin thickness and resistance, microscope settings, surgical factors such as exposure time, working distance, draping and use of irrigation, etc.) or consumables and/or other equipment used during surgery caused or contributed to the incident.The fse ensured, that "brightcareplus" has been correctly calibrated and the internal luxmeter is activated.The "brightcareplus" function has been successfully tested.The device is working according to specification.
Additional Manufacturer Narrative
Udi / gudid related data quality updates only.

• Brand Name: ARVEO 8
• 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: 18949123
• Report Number: 3003974370-2024-00003
• Device Sequence Number: 7078759
• Product Code: EPT
• UDI-Device Identifier: 07630003598872
• UDI-Public: (01)07630003598872(11)231206
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 10449063
• Device Catalogue Number: 10449063
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 07/11/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• 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