Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System Can Cause Serious Tissue Damage and/or Death

Risk Managers and Surgery healthcare personnel are informed by the US FDA that Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System can cause serious tissue damage, when used incorrectly.

Background of Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System

Neptune 1 Silver and Neptune 2 Ultra Waste Management System, by Stryker Instruments, are used for the collection and disposal of surgical fluid waste in operating rooms and surgical facilities. In addition, the Neptune 2 Ultra can remove smoke generated at surgical sites by laser devices or electrocautery.

FDA Alert on Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System

The FDA received a report of death and one report of serious injury as a result of tissue damage resulting from use of the Neptune 2 Ultra Waste Management System. These incidents indicate that the high-flow, high-suction vacuum had been incorrectly applied, with no specific warning against this action.

These Waste Management Systems can cause hemorrhaging and vital organ damage that can lead to serious injury and/or death.

Recommendation on Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System

“Healthcare providers should NOT 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.”

Contacting the FDA to report cases with Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System

In case of detection of adverse events or side effects related to the use of Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.