Additional Death & Injury Reports Linked to the Neptune Waste Management System
On March 15, 2013, the FDA alerted the public that it has become aware of additional death and injury reports related to the recalled Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems. The Neptune Waste Management System is a high-flow and high-suction vacuum designed to collect and dispose of surgical fluid waste and smoke in operating rooms and surgical facilities. This line of devices is primarily to be used for active drainage of surgical sites. The instructions for use, however, did not specifically warn against using the device for passive drainage, during which the high-suction vacuum can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.
On June 8, 2012, Stryker initiated a Class I recall of the Neptune 1 Gold, Neptune 1 Bronze, Neptune 1 Silver, and Neptune 2 Ultra Waste Management Systems following two reports of serious injury, one a fatality. Stryker specifically recalled the Neptune Systems instructions for use and replaced them with instructions that included the following language:
WARNING: DO NOT apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction, for example, passive chest drainage. ALWAYS consider the type of tissue associated with the surgical procedure BEFORE using this system. Failure to comply may result in severe injury or death.
On September 18, 2012, Stryker expanded its recall to pull the entire Neptune 1 Silver and Neptune 2 Ultra lines, as the FDA had not approved Stryker to market the devices. The FDA had not had an opportunity to review the safety and effectiveness of the Neptune Silver or Neptune 2 Ultra lines and considered Stryker’s marketing of these systems illegal.
As reported on March 15, following these recalls, the FDA became aware of additional death and injury reports associated with the Neptune 1 Silver and Neptune 2 lines resulting from improper use of the device and improper training.
The attorneys at Burg Simpson are experienced in litigation involving medical devices, and in the complex medical and legal issues concerning injuries caused by defective medical devices. If you or a loved one have suffered injury due to the use of a medical device, please contact us for a confidential consultation. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.