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FDA investigates robot recall

On Behalf of | Dec 16, 2013 | Products Liability

Families in Roanoke, Virginia, may be affected by a Food and Drug Administration investigation of a major medical supplier undergoing a worldwide recall. Federal officials are investigating surgical robots used at three hospitals in Maine because of increasing reports of malfunctions in the area. Intuitive Surgical Inc., the manufacturer of the defective product, initially issued an urgent recall on Nov. 11, 2013.

The FDA reported that the robot arms experience friction in some movements, causing them to stall as surgeons attempt to operate through the onset of resistance. The recall involves 1,386 robotic surgical units around the world. Although it’s officially a recall, all of the units are not being removed from the hospitals. Intuitive Surgical Inc. is scheduling device inspections and recommending clients inform their staff of the reported issues. Intuitive Surgical produces the $1.5 million da Vinci robot that is used in many hospitals. This machine is effective for several different procedures, including weight-surgery and removing the gallbladder.

The surgeon controls the robotic arm with hand controls while standing just a few feet away. A video device attached to the arm allows the surgeon to see inside the patient’s body. The FDA is specifically investigating the increasing number of adverse event reports regarding malfunctions, injuries or deaths. The number of reports through November 2013 more than doubled the total during 2012.

Personal injury or product liability claims with large corporations are often complicated and arduous for the victims involved. Hiring legal counsel may be important to investigate the chain of distribution and identify the party that may be liable for negligence. These types of lawyers routinely encounter personal injury cases involving vehicle lifts, children’s toys, power tools and different types of motor vehicles. Families may work with these legal professionals in an attempt to recover compensation for damages that arise from manufacturing defects or negligence.

Source: Med City News, “FDA investigating surgical robot used at three hospitals after ‘urgent medical recall'”, Jackie Farwell, December 06, 2013