A recalled surgical vacuum medical device has been blamed for causing a number of injuries and one death, primarily due to improper training for medical personnel and incomplete instructions by the manufacturer, Stryker Corporation.
The Stryker Neptune Waste Management System is a medical vacuum device that collects and disposes of fluids and medical waste during surgery. It has been linked to several injuries as well as one death. Stryker recalled several versions of the device, including the Neptune 1 Gold Rover, Neptune Gold Rover International, Neptune 1 Silver Rover, Neptune Bronze, Neptune Rover Ultra (120V) and the Neptune Rover Ultra (230V). The U.S. Food and Drug Administration (FDA) never approved these versions because the manufacturer said they were similar enough to the Neptune 1 Gold Waste Management System that already had FDA approval.
One patient died in 2012 after a Neptune medical device attached to a chest tube during lung removal surgery pulled the patient’s heart from its position, causing a fatal tear to the aorta. The FDA issued a Class 1 recall of the devices, noting that, “patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and were associated with users of the device who had not been properly trained on how to use the device. When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.”
The FDA said that Stryker failed to provide proper training and instructions for how to use the device. Specifically, the company did not warn against connecting the Neptune Rover to a passive drainage tube.
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