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

Model Number	10448704
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a combined initial/final report.A root cause investigation was performed.It was determined that the power supply's electronic component was defective, which caused the power supply to fail.It was found that the component was defective due to inadequate soldering process controls within the manufacturing of the power supply.Root cause can be traced to a weakness in the manufacturing process controls.The affected power supply was built into the surgical microscope.As a result, the power supply failed and consequently the surgical microscope had a total loss of function.Capa-lis-md-22-001 and the associated fsca (recall id: 91200) were initiated to address this issue.The defective power supply was replaced by a new one.
Event or Problem Description
Leica microsystems (schweiz) 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
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: 17860541
• Report Number: 3003974370-2023-00027
• Device Sequence Number: 5909069
• Product Code: EPT
• UDI-Device Identifier: 07630003577112
• UDI-Public: (01)07630003577112(11)220726
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 09/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RECALL ID: 91200
• Patient Sequence Number: 1
• Patient Sex: Unknown