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

Model Number	5803I
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On may 11, 2026, a report was received from (b)(6) center indicating that a patient overturned during spine surgery.Review of a follow-up call and video indicated that both the electrical and mechanical safety locking mechanisms of the table were inadvertently released, likely due to lack of user familiarity.The table subsequently rotated approximately 180 degrees, resulting in the patient turning over.Patient landed on his feet.No patient injury reported.The hospital's internal investigation concluded the event was due to user error, with staff manipulating the rear blue component and operating the remote control in an attempt to understand and release the mechanism.On (b)(6) 2026, the customer confirmed that staff training was conducted on operation of the table locking mechanisms and interpretation of indicator lights.

• Brand Name: ADVANCED CONTROL I-BASE DC INTERNATIONAL
• Common Device Name: OPERATING TABLES
• 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: 25337921
• Report Number: 2921578-2026-00015
• Device Sequence Number: 17484841
• Product Code: JEA
• UDI-Device Identifier: 00842430106002
• UDI-Public: (01)00842430106002
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 05/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown