(Reuters) - U.S. health regulators warned on Friday against the use of systems made by Stryker Corp for removing surgical waste from patients after receiving reports of one death and one serious injury due to tissue damage.
The Stryker systems, called Neptune 1 Silver and Neptune 2 Ultra Waste, use powerful suction to collect and remove surgical fluid waste in operating rooms and smoke at surgical sites caused by electrocautery or laser devices.
When incorrectly applied, as was the case with the death and serious injury, it can cause hemorrhaging and soft tissue, muscle, and vital organ damage, the U.S. Food and Drug Administration said in a warning on its website.
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, the agency cautioned.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn)
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Not good at all, where was the FMEA/risk analysis on this product? It would have taken only a couple of hours to think up that scenario had there been a proper FMEA /risk analysis done. Come on Stryker you know better, totally unacceptable.