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

Model Number	5803
Medical Device Problem Codes	Unintended System Motion (1430); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abrasion (1689); Insufficient Information (4580)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While repositioning the patient, the table showed locked, but it rotated causing the patient to fall.
Additional Manufacturer Narrative
As part of the device evaluation and preventive maintenance check, it was observed that the rotation lock located on the head end assembly is a friction lock and was worn out possibly due to repeated usage and/or abuse of the table.An evaluation of replacing the head end assembly was thus made by the manufacturer.The root cause of the observed malfunction is thus been deemed as wearing/aging of the rotation lock due to suspected frequent usage and/or abuse.
Event or Problem Description
While repositioning the patient, the table showed locked, but it rotated causing the patient to fall.

• 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: 21688730
• Report Number: 2921578-2025-00008
• Device Sequence Number: 18325604
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)180531
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2018
• 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