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

Model Number 7803

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Laceration(s) (1946); Paraplegia (2448); Respiratory Insufficiency (4462); Unintended Extubation (4564)

Event Date 04/08/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Patient securement to the table was insufficient for the desired degree of tilt.

Event 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
• Type of Device: 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
• MDR Text Key: 308063585
• Report Number: 2921578-2023-00001
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: 00842430103957
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Sex: Male
• Patient Weight: 105 KG