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

Model Number	10448950
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
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 brazil stating that a provido had a loss of function during a surgical procedure.There was no patient injury.
Additional Manufacturer Narrative
This is a final report.A root cause investigation was performed on the actual device.It was determined that there was no power output (both 12v and 24v) and the fan was also not working.The defective power supply was sent to the supplier for more in-depth fault analysis.The supplier's investigation pointed to a defective component c545 226/16v 1206.They measured +5vsb and found no output.It was confirmed that c545 showed low impedance causing a short circuit on the secondary side.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 power supply was replaced with a new one.
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: 18673857
• Report Number: 3003974370-2024-00001
• Device Sequence Number: 7216700
• Product Code: EPT
• UDI-Device Identifier: 07630003594416
• UDI-Public: (01)07630003594416(11)220329
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 10448950
• Device Catalogue Number: 10448950
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 07/17/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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