By Sarah Markley  |  May 3, 2017

Category: Legal News

Stryker Neptune 2 recall complicationsMany people are concerned that a medical device commonly used in hospitals is responsible for unnecessary Stryker Neptune patient injuries.

The Stryker Neptune is a medical device used in surgery that is designed to collect waste fluids in operating rooms and surgical facilities. The Stryker Neptune surgical waste management system can also remove smoke that is produced by surgical instruments. This device uses a high-flow, high-suction vacuum to collect these waste products.

However, the U.S. Food and Drug Administration is concerned that Stryker Neptune patient injuries may be as a result of improperly trained clinicians. When used improperly, the device can damage soft tissues, muscle and vital organs of a patient.

Stryker Neptune Injuries Lead to Recall

In fact, in June 2012 the FDA announced a Class I recall of certain Stryker Neptune products after two cases of serious tissue damage were reported. Unfortunately, one of these reports of Stryker Neptune patient injuries resulted in the death of the patient.

In this particular situation, a clinician attached a Neptune device to a passive chest drainage tube after a surgery. When this occurred, the directions on the device did not warn against doing this when passive drainage is necessary.

Just a few months later, Stryker included an additional Neptune device in the recall and issued a safety alert asking surgical technicians not to use these devices unless an alternative device was unavailable. Some surgical facilities had no choice but to continue using the Stryker devices. These facilities were forced to complete a Certificate of Medical Necessity to be sent to the company.

Early in 2013, Stryker made public the knowledge that the FDA had warned them about the fact that Stryker had marketed two devices without agency clearance, not notifying the agency about the recall and not meeting quality standards.

In another safety alert issued in March 2013, the FDA noted that even more deaths and Stryker Neptune patient injuries had been reported. The FDA wanted facilities to be aware of the fact that these reports may be related to individuals being improperly trained on how to use the devices.

However, the FDA said, if a facility must still use the devices, the facility must do the following:

  • Ensure that those who operate the Neptune devices have been trained properly.
  • Make sure the pre-checklist for the devices is followed.
  • Appoint someone at each surgical facility to ensure the pre-checklist is followed
  • Follow the recommendations from the FDA to reduce the risk for harm.

If you believe you have suffered from Stryker Neptune patient injuries, you may benefit from speaking to a Stryker Neptune attorney. You may qualify for monetary compensation.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The hip implant attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, metal hip implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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