MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG FL400 FOR M530; SURGICAL MICROSCOPE ACCESSORY

Model Number	10449183
Medical Device Problem Codes	Computer Software Problem (1112); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 germany about fl400 being unavailable during surgery.No patient injuries were reported.
Additional Manufacturer Narrative
This is a final report.A leica field service engineer inspected the affected device on-site.The customer's fl400 license for an arveo 8 system expired after 365 days instead of being permanent.An internal investigation concluded that an expired license cannot affect ongoing surgeries.The following observations were made: · expiring licenses have not only a fixed expiration date but also an expiration time.· if the system is started on the day of expiration after the expiration time has passed, the license will not be available (e.G.Fl400 function cannot be activated).· if the system is started on the day of expiration before the expiration time, the license is available and remains valid as long as the system is powered on.Additionally, the fl400 mode is not deactivated if it is active during the expiration time.Furthermore, the fl400 mode can be activated and deactivated as long as the system remains powered on, even if the license has expired in the meantime.· after the expiration time and the system is restarted, the respective license is deactivated and is no longer available (e.G., the fl400 function can no longer be activated).· in this specific case, it is clear that the license could not have expired during the surgery.It must have expired since the last usage.A review of the complaint statistics did not show any similar or identical case.The reported incident is considered an isolated event.Countermeasures are being identified and implemented as part of capa-her-md-25-003.The cause was human error: a temporary license was issued instead of a permanent one.A new permanent license has been installed.The device is functioning according to specifications.

• Brand Name: FL400 FOR M530
• Common Device Name: SURGICAL MICROSCOPE ACCESSORY
• 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; 15 tukang innovation drive; singapore, 61829 9; SN 618299
• Manufacturer Contact: manuel pfundstein ; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 23725913
• Report Number: 3003974370-2025-00013
• Device Sequence Number: 18809037
• Product Code: EPT
• UDI-Device Identifier: 07630802403414
• UDI-Public: (01)07630802403414(11)230719
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/11/2026

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
• Device Model Number: 10449183
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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