Stryker Recall of Operating Room (OR) Systems Due To Patients Being Injured During Surgery Or Surgical Procedures.
The medical device manufacturer Stryker Corporation is expanding its recall of the Neptune waste-management operating room (OR) products. Stryker company first voluntarily recalled the Neptune 1 in June of 2012 after two people were seriously injured and another died when the OR equipment was used during their surgeries. The Neptune suction system is used to collect surgical fluid, blood, waste and smoke from electrocautery or laser devices during a surgery.
Officials for Stryker said the Class 1 recall, which is the most serious recall for a medical device manufacturer, was issued because the device's label did not warn surgeons or operating room staff that the Neptune should not be connected to passive drainage tubes in the OR. When that happened, patients suffered hemorrhaging or excessive blood loss, soft tissue, muscle and organ damage or death. The Food and Drug Administration (FDA) indicated that the waste system devices are not considered "legally marketed devices because their safety and effectiveness have not yet been determined" and advises they should not be used during surgery.
On September 18, 2012, the recall was expanded after the FDA found that many other Neptune systems were never approved before they were sold to hospitals or surgical centers.
To date, the Neptune devices that have been recalled include:
- Neptune Waste Management System
- Neptune 1 Gold Rover (and International)
- Neptune 1 Silver Rover
- Neptune Bronze
- Neptune 2 Ultra (120 V)
- Neptune 2 Ultra (230 V)
Here at the Philadelphia Beasley law firm, we have a team of nurses and doctors on staff that fully understand how surgical errors or defective equipment injuries can happen during an operation even if the information is not written in the medical record, anesthesia record or operative note. Many times, a patient or family member are told that the difficulties during the operation or surgery was a risk of the surgical procedure when in fact, the injury was due to negligence or a faulty device. If you or a loved one is suffering due to a problem that happened during surgery please feel free to contact one of our experienced product liability attorneys, physicians or nurses at (215) 866-2424 for a strictly confidential and free consultation.