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

Model Number	10448704
Medical Device Problem Codes	Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 germany stating that the filter wheel of a m530 ohx had jammed during a surgical procedure.There was no patient injury.The procedure was completed successfully.
Additional Manufacturer Narrative
This is a final report.An investigation was conducted on the returned parts (illumination controller board / connector board / lamp assembly).Checked the condition of the returned parts, they were physically in good condition.Tested the functionality of white, fl800, fl400 and fl560 filters.Observed that all the filters were working fine without any abnormal noise and no errors were detected.The lamp assembly was set up in one of the production testers, and no issues were found.It was concluded that all returned parts were working in accordance to specifications.The filter wheel was sent to the supplier for further investigation.The supplier's findings: the filter wheel rotated to the correct position when operating the tester knob.No defect was found during the functional check.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 illumination controller board, connector board and lamp assembly.The system is fully functional.Correction: udi / gudid related data quality updates only.

• 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: 20212028
• Report Number: 3003974370-2024-00009
• Device Sequence Number: 12706210
• Product Code: EPT
• UDI-Device Identifier: 07630003577112
• UDI-Public: (01)07630003577112(11)190425
• 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: 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: 10448704
• Device Catalogue Number: 10448704
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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