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Neptune Surgical Waste Management Systems Recalled Due to Risk of Serious Injury and Death from High-Flow High-Suction Vacuum


 The Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra) are the subject of a Class 1 recall. The FDA and Stryker, the manufacturer, 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 fatality was the result of a customer connecting the Neptune 2 System to a passive chest drainage tube post operatively.

 

The Neptune 1 Silver Waste Management System (Neptune 1 Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra), manufactured by Stryker Instruments, 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.

 

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.

 

This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

While labeling modifications were sufficient for some of the Neptune models, the FDA determined that the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System contained other modifications, compared to prior models, that were significant enough to have warranted the submission of a new premarket notification (510(k)) by Stryker for review by the FDA.

 

However, the FDA has not cleared the Neptune 2 Ultra Waste Management System or the Neptune 1 Silver Waste Management System for marketing. On Sept. 18, 2012, Stryker mailed an updated recall notice disclaimer icon to all their customers and advised them of this issue and the steps it would take to respond to the FDA’s concerns about the safety of the device and the company’s failure to obtain FDA clearance for modifications to the original device.

 

The FDA is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. market due to concerns that removal would likely create immediate market shortages.

 

The Neptune 2 Ultra was manufactured from February 2001 through April 2012 and distributed from March 26, 2001 through Aug. 7, 2012. Stryker no longer manufacturers the Neptune Silver; however, they still maintain and support the device.

 

See the Recall

 

See the FDA Safety Announcement

 

 

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