MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS, TABLE BASE; OPERATING TABLE

Model Number	7803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clinician reports that the table kept tilting with patient on the table.Error codes 1048 and 220 c reported.Evaluation required to determine the issue.
Event or Problem Description
Clinician reports that the table kept tilting with patient on the table.Error codes 1048 and 220 c reported.Evaluation required to determine the issue.
Additional Manufacturer Narrative
Per the information obtained from the investigation and device evaluation, minor issues were found pertaining to caster locking mechanism and device battery but none of these issues are understood to have caused or contributed to the reported tilt issue.There is a remote probability of tilt lock not being applied for a brief moment when the patient was on the table but there is no evidence that indicates that.The root cause of this incident is thus deemed to be inconclusive.

• Brand Name: TRIOS, TABLE BASE
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 24110650
• Report Number: 2921578-2026-00001
• Device Sequence Number: 5430768
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: (01)00842430103957(11)240108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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
• Operator of Device: Health Professional
• Device Model Number: 7803
• Device Catalogue Number: 7803
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown