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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Table started tilting on its own with a patient on the table.Rotational safety lock was engaged as well as a 180 degree rotational lock handle.No functions on hand pendant were pressed as per staff when incident occurred.No patient injury/harm reported by staff.
Additional Manufacturer Narrative
Per the information obtained from the investigation and device evaluation, it was found that the rotational lock switch needed adjustment in order to pass the 95 ft lb test.It was also observed that the wire harness in the foot end column was modified with butt connectors and shrink wrap around each connection thus having multiple connection points with a potential of failure.The friction lock of the table, while not checked during the service visit, is suspected to have been worn off due to frequent usage.It was also noted that the table tilt was observed twice by the hospital-during the surgery and when transferring the patient to the patient bed.The hospital still chose to continue using the bed after observing the malfunction.Hence, the root cause of this incident has been deemed as multifactorial/inconclusive as there is not enough evidence to point towards a specific factor that could have caused the reported malfunction.
Event or Problem Description
Table started tilting on its own with a patient on the table.Rotational safety lock was engaged at 180 degree rotational lock handle as well.No functions on hand pendant were pressed as per staff when incident occurred.No patient injury/harm reported by staff.

• 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: 21915668
• Report Number: 2921578-2025-00010
• Device Sequence Number: 8728800
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)041210
• 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): 05/22/2025

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
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/26/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2004
• 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