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

Model Number	6875
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884); Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Death
Event or Problem Description
At the moment of patient transfer - end of a case, perineal post and belt had been removed, boots still attached to patient.Hana transfer board had not been placed for transfer assistance.Patient was left 'unattended' and fell to the floor with boots still attached.Anesthesia turned to dispose of lma equipment and provider shifted to end of table to help with feet, stretcher was pulled up to the opposite side of the table.Patient had been in scissor position for duration of case.
Additional Manufacturer Narrative
At the end of the procedure, the patient was left unattended and was not secured with a safety strap.This resulted in the patient falling from the table.The patient had a subdural hematoma and was placed under medical observation.The patient expired within 100 hours following the event.At this time, it remains unclear whether the fall contributed to the patient's death.No issues with the table were identified.Hence the route cause of the event is noted to be user error as there is a clear warning in the ifu instructing that an attendant must remain present until the patient has been safely transferred.
Event or Problem Description
At the moment of patient transfer - end of a case, perineal post and belt/safety strap had been removed, boots still attached to patient.Hana transfer board had not been placed for transfer assistance.Patient was left 'unattended' and fell to the floor with boots still attached.Anesthesia turned to dispose of lma equipment and provider shifted to end of table to help with feet, stretcher was pulled up to the opposite side of the table.Patient had been in scissor position for duration of case.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: OPERATING TABLES
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 25088709
• Report Number: 2921578-2026-00011
• Device Sequence Number: 10473401
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747(11)240129
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: Life Threatening; Death; Other
• Patient Sex: Unknown