The FDA says it knows of additional death and injury reports related to the recalled Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System. The Neptune Waste Management System is a vacuum used by surgeons to clear out smoke and fluids during surgery.
The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and [was] associated with users of the device who had not been properly trained on how to use the device… 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 and have implemented the use of the Pre-use Checklist.
Stryker provided updated recall notifications back in February for the Neptune 1 Silver and the Neptune 2 Ultra reminding customers of the steps they need to take to continue using these devices.
This is the same as the da Vinci robotic surgery malpractice lawsuits. These devices are only as good as the users… but the company has to make sure they are not giving out this equipment and saying, “Good luck.” .