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	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from india stating that a provido had a failure of the main and the back-up 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.The investigation revealed that the malfunction was caused by a short circuit in the communication cable, which subsequently led to a communication problem on the controller board.The short circuit was most likely caused by a loose contact/pin of the cable (cable adapter) on the pcba.A review of the complaint statistic did not show any case with similar or identical failure mode.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.Replacing the can handle cable effectively solved the problem.After the replacement, the device worked according to specifications and there were no further issues.
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: 18027511
• Report Number: 3003974370-2023-00030
• Device Sequence Number: 5913666
• Product Code: EPT
• UDI-Device Identifier: 07630003594416
• UDI-Public: (01)07630003594416(11)220425
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023; Not provided
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 03/21/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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