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	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient fell off the table during a case.The reason of the fall was due to the perineal post being pulled after the case with no safety straps while the patient was still on the table.
Additional Manufacturer Narrative
Per the information obtained from the investigation, the perineal post and safety straps were removed while the patient was still on the table causing the patient to fall.No patient injury was reported as a result of the fall.While there was no information obtained on how many people were tending to patient post-surgery/patient transfer phase, there is sufficient information identified in the device owner's manual regarding the usage of patient safety straps and perineal post.The root cause of this incident is thus deemed to be use error as there was failure to follow manufacturer's best and recognized practices for patient safety.
Event or Problem Description
It was reported that a patient fell off the table during a case.The reason of the fall was due to the perineal post being pulled after the case with no safety straps while the patient was still on the table.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: OPERATING TABLE
• 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: 24565194
• Report Number: 2921578-2026-00005
• Device Sequence Number: 8829070
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747(11)230724
• 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): 03/31/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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