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	02/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient fall from hana orthopedic surgical table was reported.Instead of using the safety strap, a silk tape was used to secure the patient causing the fall.
Additional Manufacturer Narrative
Per the information obtained from the patient's attorney, it was reported that the hospital did not use the safety straps as recommended in the owner's manual and instead used a silk tape to secure the patient causing a patient fall.Per the information obtained from hospital's attorney, the reported injuries were disputed and incident did not result in a serious injury or death.Information pertaining to device serial number or its usage was not obtained.While the reported incident looks like use error, the reported incident or the injury was not confirmed by the hospital.The root cause of this incident thus has been deemed as inconclusive.
Event or Problem Description
A patient fall from hana orthopedic surgical table was reported.Instead of using the safety strap, a silk tape was used to secure the patient causing the fall.

• 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: 20571149
• Report Number: 2921578-2024-00021
• Device Sequence Number: 8226726
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female