MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS, TABLE BASE; OPERATING TABLE

Model Number	7803
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a woman fell from the trios table when it was tilted.She wasn't strapped around the top.The table was barely tilted when she fell off and hit her head.A couple days later doctors told the fse that it wasn't a jerk but slight movement in the head in assembly.Fse told them maximum movement is two degrees (clockwise and counterclockwise) and it measured around 1 at the time of inspection so it is fine.
Event or Problem Description
It was reported that a woman fell from the trios table when it was tilted.She wasn't strapped around the top.The table was barely tilted when she fell off and hit her head.A couple days later doctors told the fse (field service engineer) that it wasn't a jerk but slight movement in the head in assembly.Fse told them maximum movement is two degrees (clockwise and counterclockwise) and it measured around 1 at the time of inspection so it is fine.
Additional Manufacturer Narrative
Based on the information obtained from the investigation, it was found out that there were no problems with the device.The patient was positioned prone on the spinal top for a rf ablation procedure with a single strap, across the upper thighs, below the gluteal fold.The table had been tilted for improved visualization.When they went to level the table, the patient's upper body came loose and slid off.No injuries to the patient were identified.The ifu of the device has instructions pertaining to the application of buttock strap and leg safety strap and suggests an additional safety strap may be applied around the upper body as applicable.The placement and location of the straps are still at the discretion of the surgeon and vary by procedure.The exact cause of this event thus remains unknown as multiple factors such as challenging habitus, non-optimal usage of positioning and safety strap and/or surgeon's discretion could have contributed to the observed patient fall.

• Brand Name: TRIOS, TABLE BASE
• 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: 19525178
• Report Number: 2921578-2024-00005
• Device Sequence Number: 7512997
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: 00842430103957
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: Female