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A number of patients were injured when a medical device was used during their surgery as a routine part of the surgical procedure performed in the operating room.
The Neptune waste management system is the device that allegedly caused the patient injuries. This device is used as a medical waste collection unit primarily for fluid waste, but it can also collect the smoke produced during electrocautery or by the use of laser devices.
In September 2012, Stryker issued a recall of its Neptune waste management system. The following month, the FDA issued a Safety Communication related to the device. This communication was updated a number of times, and the most recent update in June 2014 provided new guidelines to the facilities using the Neptune system.
One of the original FDA communications issued March 2013 said that facilities could continue using the Neptune waste management system, but they needed to have an updated Certificate of Medical Necessity to use the recalled devices. The update included additional safety precautions to be taken with the use of the Neptune system and advised facilities to transition from using the device.
The FDA recommended using alternative devices to the Neptune systems that were legally marketed to be used as a waste management system. The agency also said that if no alternative existed, facilities must take additional steps to appropriately use the device under the terms of the Certificate of Medical Necessity.
Additionally, the FDA update informed facilities that Stryker was not going to be pursuing FDA 510(k) clearance for the device and that the company would withdraw all of its product support for the Neptune system by March 1, 2014. No devices should be used after March 1, 2014, the FDA says.
The Neptune waste management system, if used improperly, could result in the serious injury or death of patients.
“When used incorrectly, the high-flow, high-suction vacuum can cause hemorrhaging of soft tissue, muscle, and vital organ damage that can lead to serious injury or death,” the 2014 FDA communication states.
“For example, in one report, a patient died after the Neptune was connected to the chest tube during a pneumonectomy and the suction pulled the heart muscle from its left position in the chest, causing a tear in the aorta.”
Legal Action Taken over the Neptune Waste Management System
A number of Neptune lawsuits have been filed against Stryker, the manufacturer of the Neptune system, by patients and loved ones who have been injured as a result of the use of the device during their surgery.
In one particular case, the patient alleged that use of the device while it was attached to the patient’s surgical drains caused the patient to lose a lot of blood. This blood loss caused the patient’s heart to stop beating, and the patient had to be resuscitated.
After surgery, the patient suffered from a number of serious health problems allegedly caused by the waste management system.
If you developed serious complications following the surgery where the Neptune waste management system was used, you may be entitled to seek legal compensation for your injuries. An experienced attorney can review your case at no charge and can help you decide if filing a Stryker Neptune lawsuit is the right course of action for you.
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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