Stryker Neptune Waste Management System is the subject of a recent FDA recall and safety alert. The non-FDA approved device can cause bleeding as well as soft tissue, muscle and vital organ damage.
The Stryker Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.
Stryker Device Was Not FDA Approved
The recall and alert are a result of two serious injuries, including a death. The device, the Stryker Neptune Waste Management System, is a medical device that has never gained regulatory approval.
Stryker was forced to issue a Class I recall on three models of its Neptune Waste Management System after receiving two reports of malfunctions that caused patients serious injury or death. A Class I recall is the most serious recall, which indicates usage of that device is likely to cause serious injuries or death.
In one of the incidents that prompted the recall, a patient’s passive chest drainage tube was connected to the Neptune 2 system, a model that features a strong vacuum and high flow. Due to complications during the surgery caused by the malfunctioning device, the patient died.
In statement by Stryker, the company admits that the FDA does not consider the Neptune waste removal systems to be safe or effective because it hasn’t approved them for use during surgeries. Prior to a medical device or other pharmaceutical product being released to the market, the manufacturer must have it endure extensive clinical testing to ensure its safety and effectiveness. The FDA is supposed to have time to review these studies for accuracy and potential conflicts-of-interest before giving it a final OK and putting it on the market.
As such, Stryker has ceased marketing and distributing the Neptune devices. The FDA recommends that 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. Facilities should evaluate the risks and benefits of using the Neptune 1 Silver or the Neptune 2 Ultra. If the facility does not have an alternative means for surgical waste disposal during surgery, the facility must complete the Certificate of Medical Necessity and send it back to Stryker. The Certificate of Medical Necessity must be filed with Stryker by Oct. 12, 2012 in order to continue to receive supplies and customer support for this device.