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	Head Injury (1879)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient fall was reported while preparing for the transfer from the hana table to the gurney.The patient was not in the traction boots, not strapped in and the perineal post was removed.The staff was not paying attention to the unsecured patient causing the patient to fall.The fall caused the patient's head to crack and subsequent bleeding.There were no problems with the table itself.
Additional Manufacturer Narrative
Per the information obtained, there were no problems reported with the device itself.The patient was not secured via safety straps and perineal post along with lack of attention of the personnel.The owner's manual of hana table mentions the techniques of securing patient safely while transferring to and from the surgical table along with necessary cautions/warnings to alert the end-user if the safety straps and perineal post are not used.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.Information regarding patient status following the fall and hospital's approach of treatment/mitigation is still unknown at this time.
Additional Manufacturer Narrative
The only information obtained from the investigation were the following patient details- age, sex, weight and race of the patient.Information regarding the patient status following the fall and the treatment/mitigation approach was not obtained from the hospital.
Event or Problem Description
A patient fall was reported while preparing for the transfer from the hana table to the gurney.The patient was not in the traction boots, not strapped in and the perineal post was removed.The staff was not paying attention to the unsecured patient causing the patient to fall.The fall caused the patient's head to crack and subsequent bleeding.There were no problems with the table itself.

• 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 84587-1234 ; 5104291500
• MDR Report Key: 20192910
• Report Number: 2921578-2024-00020
• Device Sequence Number: 15349310
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747(21)2019-2825
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 09/06/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2019
• 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
• Patient Sex: Female
• Patient Weight: 48 KG