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U.S. Department of Health and Human Services

Safety

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Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage

 

[Posted 10/05/2012]

AUDIENCE: Risk Manager, Surgery

ISSUE: The 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.

BACKGROUND: 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.

RECOMMENDATION: Healthcare providers should NOT to 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 your facility does not have an alternative means for surgical waste disposal during surgery, you must complete the Certificate of Medical Necessity and send it back to Stryker. The facility must file a Certificate of Medical Necessity with Stryker by Oct. 12, 2012 in order to continue to receive supplies and customer support for this device. See the FDA Safety Communication for additional information and recommendations.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[10/05/2012 - FDA Safety Communication - FDA]

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