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.
"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.
The Neptune devices collect and dispose of surgical waste during operations. The original recall, issued June 5, warned customers against connecting the Neptune systems to high-powered surgical sucking systems after 1 patient suffered tissue damage and died during such a procedure.
Certain healthcare providers opted to continue using the Neptune waste managers, submitting a "Certificate of Medical Necessity," in which the clinics accepted the risks of the device and promised to properly warn and train all users.
The CMN required that clinics acknowledged that "FDA does not consider the Neptune Silver or the Neptune 2 to be legally marketed devices
because their safety and effectiveness have not yet been determined," and further "certify that all users of the Neptune Silver and/or Neptune 2 at this medical facility have been informed of the contents of this notification and adequately instructed in the risk and benefits of this device and its proper use."
The new FDA warning noted that clinics that choose to continue using the recalled systems must take additional steps in order to do so, and that they must phase out the recalled Neptune devices by March 1, 2014, when Stryker will cease providing all support for the systems.
Earlier this month Michigan-based Stryker reported that the FDA sent it a warning letter stemming from an November 2012 inspection of a plant in Portage, Mich. The company said the letter, based on "quality system observations," flagged it for failing to tell the federal watchdog agency of a product recall and for marketing devices including its Neptune waste management system without 510(k) clearance from the FDA.