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 Codes	Aspiration/Inhalation (1725); Fall (1848)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient fell off of the hana table while still intubated, this was at the end of a surgical procedure.Staff was not standing next to the patient and the patient did not have a restraint strap in position to hold them on the hana table, the perineal post was still in place.
Additional Manufacturer Narrative
Based on the information obtained from the investigation, no problems were found with the device itself.Safety straps were not used throughout and after the surgical procedure.There is also no indication or evidence that enough personnel was present to support the patient transfer from the surgery table to the bed.The instructions for use of the hana table highlights the importance of using the safety straps, subsequent cautions and warnings for not using the safety straps along with a focus on handling requirments of the unsecured patient on and off the table.This incident is thus deemed as a use error as there was a failure to follow manufacturer's recommended guidelines and recognized best practices for patient safety.
Event or Problem Description
Patient fell off of the hana table while still intubated, this was at the end of a surgical procedure.Staff was not standing next to the patient and the patient did not have a restraint strap in position to hold them on the hana table, the perineal post was still in place.

• 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: 19818300
• Report Number: 2921578-2024-00011
• Device Sequence Number: 15624358
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White