MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TABLE, HANA, 110 V; OPERATING TABLE

Model Number	6875
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was dropped while being transferred from hana table to the transport bed.No injuries to the patient were reported.
Additional Manufacturer Narrative
Per the information obtained from investigation and device evaluation, it was confirmed that there were no issues with the table itself.The patient was dropped during a transfer from hana table to the transport bed post surgery.Patient was reported to be doing fine.There is sufficient information in the owner's manual regarding transfer of patient to and from the hana table.While there was no evidence obtained regarding how many people were involved during the transfer process, the patient was still dropped somehow from during the transfer.This incident is thus deemed as use error.

• Brand Name: TABLE, HANA, 110 V
• 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: 22928699
• Report Number: 2921578-2025-00014
• Device Sequence Number: 10389770
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747(11)220511
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: 6875
• Device Catalogue Number: 6875
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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