The U.S. Food and Drug Administration (FDA) said Friday it has received additional death and injury reports involving Stryker Corp. surgical devices, which never received FDA approval.
There are two types of devices called the Neptune Waste Management System, which involve a vacuum used to assist in the removal of fluids from patients during surgery. The Neptune Waste Management System is intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities.
The devices were recalled last year following the death of one patient and injury of another when the high-suction vacuum was improperly applied, according to the FDA.
Stryker Corp, orthopedic implant maker, received a warning letter from the FDA relating to quality concerns at its Portage, Michigan facility.
The letter, which followed an inspection of the facility in November, also noted that Stryker failed to notify the regulator of a product recall and had been marketing devices without the required approvals.
In October, the FDA warned surgical facilities to stop using the devices if possible, and Stryker placed warning labels on devices that were already in use. The company did stop producing one of the Neptune devices and is seeking FDA approval for its Neptune 2 Waste Management System. It is unclear why the devices did not go through the FDA clearance process or if it was even required.
Stryker manufactured the Neptune 2 device from 2001 through April 2012, according to the FDA.
The FDA’s website posted a new notice Friday stating that it received another report of the death of a patient and two more cases of injuries in facilities that had been allowed to continue the use of the Neptune devices.
Earlier this past week, Stryker said they received an FDA warning letter, partly for marketing the Neptune devices without agency permission and for failing to notify the FDA about the initial device recall. Stryker did not immediately provide additional comments on Friday.
The FDA said that they and the company were “particularly concerned” about the new cases, since facilities continuing to use the devices were supposed to ensure that all users were adequately trained.
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