FDA Issues Safety Communication for Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System
Published: Oct 9, 2012
The U.S. Food and Drug Administration (FDA) and Stryker received one report of serious injury and one report of death as a result of tissue damage resulting from use of the Neptune 2 Ultra Waste Management System. The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action. 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.
The Neptune 1 Silver Waste Management System (Neptune Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra) are intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities. 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.
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