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

Model Number	5803
Medical Device Problem Codes	Use of Device Problem (1670); Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the information available, the user pulled the "t-pin" out of the tabletop with patient on the table.The ifu of the table base has following warnings regarding the usage of the t-pin.1.T-pins extended through the crossbars and tabletop supporting the patient should never be removed with the patient on the tabletop.Removing these t-pins may result in harm to the patient, healthcare workers or the device.2.Failure to install the t-pin properly through one side of the h-frame, passing completely through the tabletop mounting tube, and then through the opposite side of the hframe with the drop lock visible and pivoting freely, may result in harm to the patient, healthcare workers or the device.This incident has thus been deemed as a use error.
Event or Problem Description
It was reported that the end user pulled the t-pin out of the table causing the table top to fall off the table base with patient on the table.No patient injury/harm reported.
Additional Manufacturer Narrative
Additional information obtained from the investigation confirmed that there was a patient fall but no injury was reported.The table was confirmed to be functioning okay as per the specifications.The user pulled the t-pin out of the table with patient on it.The ifu was reviewed and found to be sufficient with warnings regarding the usage of t-pins.The incident has thus been deemed as a use error as there was a failure to follow instructions and recommended practices for patient safety and device usage.
Event or Problem Description
It was reported that the end user pulled the t-pin out of the table causing the table top to fall off the table base with patient on the table.No patient injury/harm 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: 21689305
• Report Number: 2921578-2025-00009
• Device Sequence Number: 8774084
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026(11)100712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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?: No
• 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: 07/12/2010
• 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