The Stryker Neptune Waste Management System is a device that uses high-powered vacuum to suck up bodily fluids during an operation. Unfortunately, one person was injured and one person died after healthcare workers mistakenly attached the vacuum to passive chest drainage tubes — causing severe organ damage and tissue damage. Even more troubling, several types of Stryker Neptune systems were never approved by the FDA before they were sold to clinics around the world.
Do I Have a Stryker Neptune Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by the Stryker Neptune Waste Management System, you should contact our lawyers immediately. You may be entitled to compensation by filing a Stryker Neptune lawsuit.
What is the Stryker Neptune Surgical Waste Management System?
The Stryker Neptune Waste Management System is a medical device that is used in the operating room. It consists of a high-powered, high-volume suction system which removes fluids (primarily blood) from a patient. Waste is sucked into a disposal system, which reduces healthcare workers’ exposure to fluids during the operation, and also packages the waste in a way that limits handling.
What is the problem?
Stryker and the FDA have received one report of injury and one report of death caused by the Neptune 2 Ultra Waste Management System. The problem is that the instructions on the devices do not specifically warn against attaching the high-powered, high-volume vacuum to a patient’s passive drainage tube. The FDA has warned:
“When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.”
Stryker Neptune Recall
Stryker first recalled the Neptune Waste Management System in June 5, 2012, after receiving two injury reports, including one death. On September 18, 2012, the recall was expanded after the FDA found that several Neptune systems lacked approval from the FDA.
The recall is a Class 1 recall, which is the most serious recall, reserved for devices that have a good probability of causing severe injury or death.
The recalled device include:
- Neptune Waste Management System
- Neptune 1 Gold Rover (and International)
- Neptune 1 Silver Rover
- Neptune Bronze
- Neptune 2 Ultra (120 V)
- Neptune 2 Ultra (230 V)
FDA Warning for Stryker Neptune Waste Management System
On October 5, 2012, the FDA published a Safety Communication to warn about the risk of using the Stryker Neptune system.
According to the FDA,
“Healthcare providers should NOT use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available.”
Stryker Neptune Lacks FDA Approval
The Neptune 1 Silver, Neptune 2 Ultra (120 V), and Neptune 2 Ultra (230 V) were sold without FDA approval.
The FDA asked Stryker to recall the products because they require, but do not currently have, 510(k) clearance. The 510(k) approval system is for new devices that are similar to approved devices. Manufacturers do not need to conduct new studies for 510(k) devices, but they do need to gain approval before they can sell their product.
The FDA warns:
“At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”
Do I have a Stryker Neptune Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Stryker Neptune lawsuit review.