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

Model Number	10448976
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from great britain 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.The field service engineer conducted an on-site investigation and found a problem with the left can handle.The problem was due to a short circuit, which subsequently led to the reported illumination failure.The short circuit in the can handle could be caused by the following: 1.Crimping of the can wires to the housing during assembly.2.The can cable connector is too close to the metal clamp, causing the can cable shield wires to short to the exposed wire of the can connector.3.The can cable wires got cut by the sharp edge of the metal clamp.The cause can be traced to a manufacturing process problem.Corrective actions have already been implemented at the supplier, and the assembly process has been improved.These activities are covered under dive-lis-md-23-011 (improvement project).The short circuit in the left can handle was repaired by the field service engineer.

• 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: 21684964
• Report Number: 3003974370-2025-00003
• Device Sequence Number: 9234882
• Product Code: EPT
• UDI-Device Identifier: 07630003594423
• UDI-Public: (01)07630003594423(11)240319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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