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

Model Number	5803I
Medical Device Problem Codes	Use of Device Problem (1670); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, an incident was observed in which the treatment plate locking mechanism appeared to be in the closed position but was not fully engaged.As a result, during table tilt, the plate moved to an extreme tilt position.A thorough inspection of all mechanical components was conducted, and all were confirmed to be functioning as intended.Attempts to replicate the issue under controlled simulation conditions were unsuccessful.Following discussions with the medical staff present, including the surgeon and anesthesiologist, it was determined that the locking handle had not been fully secured.The staff was subsequently instructed on verifying full locking engagement prior to use.After completion of all inspections, the table was confirmed to be operating correctly.At the request of the biomedical engineering department, the locking handle alignment was adjusted on all tables of the same model, and all units have been cleared and are ready for operation.No patient injury was reported.

• Brand Name: ADVANCED CONTROL I-BASE DC INTERNATIONAL
• Common Device Name: OPERATING TABLES
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 24955754
• Report Number: 2921578-2026-00008
• Device Sequence Number: 10093270
• Product Code: JEA
• UDI-Device Identifier: 00842430106002
• UDI-Public: (01)00842430106002(11)120222
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 5803I
• Device Catalogue Number: 5803I
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2012
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2012
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown