The robot is classified as a medical device and the big problem and reason for the recall is the arm that can “stall” when a surgical procedure is being done. Software maybe, just like your computer does with a short stall and then it catches up. In addition there has been a lawsuit filed against the company from an insurance company in Illinois.
The insurance suit claims Intuitive concealed information about legal risks with the device. The number of system malfunctions, injuries and even deaths connected with the robotic device have doubled in 2013 compared with 2012. BD
A da Vinci robot recall was announced on Tuesday by the U.S. Food and Drug Administration, after the manufacturer, Intuitive Surgical, issued a “voluntary product correction” for da Vinci Patient Side Manipulators (PSMs). Intuitive Surgical warned the mechanical arms on some of its da Vinci robots could stall during robotic surgery.
The FDA states this is a Class II medical device recall, which means the agency believes the problem could typically result in temporary or medically reversible health issues, but could also pose a risk of serious injury in rare cases.
Intuitive Surgical warned hospitals and other medical providers that the robot’s instrument arms need to be replaced. It announced it is inspecting affected robots and repairing or replacing the arms when necessary. The company claims nearly 70% of the inspections had been completed and the majority of the arms did not need adjustment. The recall affects 1,386 Patient Side Manipulators on da Vinci S, Si and Si-e Surgical Systems.
In May, Intuitive Surgical issued a warning to health care providers about problems with the da Vinci robot cauterizing scissors, stating the components may develop micro-cracks that allow electrosurgical energy to cause thermal injury or burns to internal organs
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