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

Model Number	10448976
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 turkey stating that a provido had a loss of function during a surgical procedure.There was no patient injury.The facility where the incident occurred cannot remember the day of the event and therefore cannot provide an exact date.November 26, 2024 is the day on which leica microsystems (switzerland) ag became aware of the incident.Therefore, this date has been entered as the date of event.
Additional Manufacturer Narrative
This is a final report.An investigation was conducted on the returned power supply.The power cord was connected to the power supply and plugged to the tester.Both the metal plates that gang the 3 x 24v ports were removed to facilitate the voltage verification on individual 24v deck.The voltage measurement on all 4 ports (1 x 12v & 3 x 24v) were verified to be correct.The returned power supply was confirmed to be no trouble found.This is consistent with the fse's on-site findings.The fse determined that the system was operating normally and all voltages were normal.The power supply was sent to the supplier for further investigation.The supplier's findings: ac voltage is applied, input current is present, output voltage is present, and all output voltages are normal.The load test is normal.A review of the manufacturing and service records did not show anything that could explain the reported complaint.A review of the complaint statistics did not indicate an adverse trend.Fse replaced the ac/dc power supply as a precautionary measure.

• 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: 20889753
• Report Number: 3003974370-2024-00010
• Device Sequence Number: 13022656
• Product Code: EPT
• UDI-Device Identifier: 07630003594423
• UDI-Public: (01)07630003594423(11)211125
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 03/19/2025

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: 10448976
• Device Catalogue Number: 10448976
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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