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

Model Number	10448700
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from tunisia stating that a provido had a loss of illumination during a surgical procedure.There was no patient injury.
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.A root cause investigation was performed on the actual device.It was determined that the zoom controller board has no power and there is no display on the front of the optics carrier.The motor controller board was also tested and it was found that the board receives power but the focus does not work.Both boards were found to be faulty.Based on the failure described by the fse, the zoom controller board had burned out and therefore had no power and could not operate the optics carrier.A review of the manufacturing and service records did not reveal any issue that could explain the complaint.Based on the identified root cause along with the review of the complaint statistic, it can be concluded that the reported issue is an isolated, random component failure with no indication of design or manufacturing issues and no evidence of an adverse trend.The defective zoom and motor controller boards were replaced with new ones.
Additional Manufacturer Narrative
Udi / gudid related data quality updates only.

• Brand Name: PROVIDO
• 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: 18700672
• Report Number: 3003974370-2024-00002
• Device Sequence Number: 6205213
• Product Code: EPT
• UDI-Device Identifier: 07630003577105
• UDI-Public: (01)07630003577105(11)210818
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: 10448700
• Device Catalogue Number: 10448700
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 07/17/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2021
• 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