MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number	5803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the during a procedure, patient on the bed rotated abruptly on its own.No injury reported.
Additional Manufacturer Narrative
Per the information obtained from investigation and device evaluation, there was a faulty friction ring found at the foot-end of the table.The reported "abrupt motion/rotation" of the table was deemed not reproducible by the manufacturer.The friction ring is part of a brake that contributes in the control of tilt/rotation mechanism of the table.Due to the age of the table (12+ years) the probability of the friction ring being subjected to normal wear & tear is fairly high and this could have been one of the factors (if not the only factor) that may have caused the reported "abrupt motion/rotation" of the table.
Event or Problem Description
It was reported the during a procedure, patient on the bed rotated abruptly on its own.No injury reported.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• 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: 22511573
• Report Number: 2921578-2025-00013
• Device Sequence Number: 8788532
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)120723
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/15/2025

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
• Device Model Number: 5803
• Device Catalogue Number: 5803
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2012
• 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