MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MTS SPINAL SURGERY TOP; SURGICAL TABLE

Model Number 5943

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

A (b)(6) female patient with lumbar spinal stenosis underwent posterior lumbar spinal fusion and posterolateral interbody fusion under general anesthesia.When the patient was positioned prone on the jackson spine table before the surgery, a sudden severe hypotension and hemodynamic collapse developed.This circulatory collapse was refractory to intravascular volume expansion, inotropes and vasopressors.Application of external abdominal support immediately restored hemodynamics.The jackson spine table allowed the abdomen to hang freely, providing abdominal decompression as well as resulting in the severely sagged abdomen.We suspected that the sagging abdomen pulled the abdominal contents downwards kinking the inferior vena cava or caused venous pooling in the abdomen, resulting in the obstruction of venous return to the heart.The patient successfully underwent the surgery with the external abdominal support and there were no postoperative complications including abdominal compartment syndrome.

Event Description

A 75-year-old female patient with lumbar spinal stenosis underwent posterior lumbar spinal fusion and posterolateral interbody fusion under general anesthesia.When the patient was positioned prone on the jackson spine table before the surgery, a sudden severe hypotension and hemodynamic collapse developed.This circulatory collapse was refractory to intravascular volume expansion, inotropes and vasopressors.Application of external abdominal support immediately restored hemodynamics.The jackson spine table allowed the abdomen to hang freely, providing abdominal decompression as well as resulting in the severely sagged abdomen.We suspected that the sagging abdomen pulled the abdominal contents downwards kinking the inferior vena cava or caused venous pooling in the abdomen, resulting in the obstruction of venous return to the heart.The patient successfully underwent the surgery with the external abdominal support and there were no postoperative complications including abdominal compartment syndrome.

Manufacturer Narrative

This is the first reported instance, and the attending physicians were able to understand and resolve the problem.Park jh, kwon jy, lee se, kim yh, kim sh.Sudden hemodynamic collapse after making prone position on the jackson spine table for spinal surgery.Korean j anesthesiol.2018 dec 28.Doi: 10.4097/kja.D.18.00339.[epub ahead of print] - attachment: [kja-d-18-00339.Pdf].

• Brand Name: MTS SPINAL SURGERY TOP
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8290596
• MDR Text Key: 134523392
• Report Number: 2921578-2019-00003
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 78