FDA blames poor training for new deaths, injuries tied to Stryker's recalled Neptune systems

March 19, 2013 by Arezu Sarvestani

In the months since Stryker's September 2012 recall of its Neptune surgical waste management systems, the FDA noted additional deaths and injury reports in clinics that opted to continue using the device.

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The FDA this month issued updated warnings to clinics still using Stryker's (NYSE:SYK) recalled Neptune 1 Silver or Neptune 2 Ultra surgical waste management systems, noting that there have been additional deaths and patient injuries since Stryker initiated the recall last year.

The adverse event reports indicated that user errors were behind the patient injuries and that clinic workers hadn't been properly trained prior to using the device, according to the updated FDA notice.

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"Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the [Certificate of Medical Necessity] is to ensure that all users are adequately trained," the FDA reported. "When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death."

Stryker initially pulled certain Neptune systems in June 2012, updating the recall to include additional models after the company received reports of serious injuries that resulted in 1 patient death.