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

Model Number	10448800
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/08/2024
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 switzerland stating that during an operation with a proveo 8, the binocular tube fell on the patient, causing a minor injury described as a bruise on the nose.
Additional Manufacturer Narrative
This is a final report.An investigation of the actual device was conducted.The fse found that the binocular tube was not properly mounted and showed signs of edge wear.The surgical staff regularly remove/install the main binocular tube as the laser filter remains installed only when needed.In this case, the tube was obviously not installed properly and fell on the patient.A review of the service history records revealed no issues that could explain the complaint.The review of the complaint statistics and the relevant instructions for use did not indicate any systemic problem with the device or associated labelling.A review of the user manual showed that the relevant instructions are adequate.Based on the investigation results, it can be concluded that the binocular tube was not properly mounted as stated in the user manual.The reported incident can be traced to the user not following the instructions for use.The damaged binocular tube was replaced with a new one.The device works according to specification.The users have been re-trained on how to properly mount the binocular tube.
Additional Manufacturer Narrative
Udi / gudid related data quality updates only.

• Brand Name: PROVEO 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: 20014806
• Report Number: 3003974370-2024-00006
• Device Sequence Number: 11852895
• Product Code: HRM
• UDI-Device Identifier: 07630003581799
• UDI-Public: (01)07630003581799(11)171220
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: 10448800
• Device Catalogue Number: 10448800
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/07/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2017
• 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