MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG M530 OHX; SURGICAL MICROSCOPE

Model Number	10448737
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Leica microsystems (b)(6) ag received a complaint from usa stating that a m530 ohx had a loss of function 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 returned power supply was examined.It was connected to a test device and turned on.All leds on the 5 decks illuminated.The voltage of all five decks was measured and confirmed to be within specifications.No problems with the power supply were found.The investigation by the local fse pointed to environmental conditions, as the system appeared to shut down simultaneously with the room's air conditioning being switched off.The power supply may have failed under unfavorable environmental conditions and recovered after the air conditioning was switched on.Prolonged operation in poorly ventilated rooms could have led to overheating of the power supply and thus to the reported shutdown.The outgoing inspection report was reviewed.It confirmed the power supply was working correctly, had been tested, and met specifications.All test parameters, such as input current testing, leakage current testing, light intensity measurements, and electrical safety testing, met specifications.A review of the manufacturing and service records revealed no evidence of problems that could be associated with the reported incident.A review of the complaint statistics did not show any similar or identical case.The reported malfunction is considered an isolated event and does not indicate a design or manufacturing issue.The power supply has been replaced.Correction to section h4.The manufacturing date of the device was august 16, 2024.

• Brand Name: M530 OHX
• 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: 23494108
• Report Number: 3003974370-2025-00009
• Device Sequence Number: 8993282
• Product Code: EPT
• UDI-Device Identifier: 07630003579642
• UDI-Public: (01)07630003579642(11)240816
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 12/17/2025

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: 10448737
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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