MAUDE Adverse Event Report: MIZUHO OSI TRIOS SURGICAL TABLE; OPERATING TABLE

Model Number	7803
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unintended Extubation (4564)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident of patient falling from the table was reported.An operational check of the table was performed which concluded having no problem with the table.It was reported by or lead coordinator that one of the nurses had put some foot boards on the table which caused the incident of patient fall.This was deemed as operator's error with no reports of patient injury.
Additional Manufacturer Narrative
A fall was initially reported in relation to mizuho osi table.After communicating with user facility, they indicated that mizuho osi table was not involved in the incident.Thus, the initial report was erroneous.
Event or Problem Description
An incident of patient falling was reported.
Additional Manufacturer Narrative
Patient securement to the table was insufficient for the desired degree of tilt.
Event or Problem Description
Procedure was t5 to t10 laminectomy with microscopic dissection and tumor resection.Patient was prone, lower body secured to table.The table was airplaned to improve surgical access.Patient slid off the table onto the floor.

• Brand Name: TRIOS SURGICAL TABLE
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 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 ; 2104291500
• MDR Report Key: 14161950
• Report Number: 2921578-2022-00006
• Device Sequence Number: 2946130
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: 00842430103957
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

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: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 04/11/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/27/2022; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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: Male
• Patient Weight: 105 KG