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

Model Number	10448737
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a final report.An investigation was performed on the returned part.The affected screw was analyzed by an independent laboratory.The examination included a visual inspection, a microscopic examination, and a scanning electron microscope analysis.Additionally, leica microsystems (schweiz) ag conducted a design review of the swing arm based on the independent laboratory report.No evidence of the reported malfunction was found.The screw broke at the joint between the arm and the strut (ball bearing with bushing).The root cause cannot be definitively determined.Different factors could have contributed to the failure.However, it is suspected that organic contaminants entered the ball bearing over time, causing the bushing to stick or jam.When the arm was moved, torque was transferred through the ball bearing to the sleeve and then to the screw, resulting in abrasion and eventual failure.A review of the service records and assembly instructions 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 broken screw was replaced with a new one according to released service procedures.The m530 ohx system has been tested and is operating according to specifications.Additional information: in the initial report, the contact details of the initial reporter were unknown.This final report provides the missing information; see sections e.1, e.2 and e.3.
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from china stating that the horizontal arm of an m530 ohx came loose.There was no patient / user 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.

• 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: 22370366
• Report Number: 3003974370-2025-00005
• Device Sequence Number: 19987781
• Product Code: EPT
• UDI-Device Identifier: 07630003579642
• UDI-Public: (01)07630003579642(11)180409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2018
• 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