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

Model Number	7803
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946); Paraplegia (2448); Respiratory Insufficiency (4462); Unintended Extubation (4564)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient fell off the operating room table midway through the procedure causing the endotracheal tube and surgical spreaders to be ripped out of place.The doctor stated that they were tilting the bed when the patient slipped off and fell to the floor.The following morning patient was alert and oriented but paralyzed from the waist down.Unfortunately, he passed away a couple of days later due to paralysis and respiratory insufficiency.
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 OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16238013
• Report Number: 2921578-2023-00001
• Device Sequence Number: 17730372
• 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: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 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: Death; Other
• Patient Sex: Male
• Patient Weight: 105 KG