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

Model Number	5803
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient fell from mts table.The table was used for a surgical procedure without a t-pin.When the patient was being transferred from the operating to the gurney, the head side of the table dropped causing the patient to fall.
Event or Problem Description
Patient fell from mts table.The table was used for a surgical procedure without a t-pin.When the patient was being transferred from the operating to the gurney, the head side of the table dropped causing the patient to fall.
Additional Manufacturer Narrative
Per the information obtained from the investigation, no problems with the device were found.The hospital staff failed to ensure that the required number of t-pins were used to fully secure the frame of the table.Without all the required t-pins, the table base was not attached to the table top properly.When the hospital staff attempted to transfer the patient, the table base fell along with the patient as the installation of the table base to the table top was improperly done.Per the hospital, the patient was not injured following the fall.The instructions for use/owner's manual of the device has adequate instructions pertaining to use of t-pins during installation of the table top and subsequent use during surgical procedures along with and applicable warnings regarding the patient harm in case of not using the t-pins properly.This incident is thus deemed as use error as there was a failure to follow manufacturer's instructions and guidelines for safe usage of the device.The hospital staff were educated and re-trained by mizuho osi personnel following the incident.

• 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: 20103620
• Report Number: 2921578-2024-00018
• Device Sequence Number: 7794824
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 08/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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