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FDA Investigating Surgical Robots Used at Hospitals

By Brian Chase on January 6, 2014 - No comments

davinci roboticsA surgical robot that is being used by three Maine hospitals is under scrutiny by officials with the U.S. Food and Drug Administration (FDA) following reports that the units may stall during procedures. According to a report in the Bangor Daily News, Intuitive Surgical Inc., the maker of the $1.5 million da Vinci robotic surgery system, issued an urgent medical device recall in November alerting customers that friction in the instrument arms of some of the robots can cause them to stall momentarily. The FDA had also issued a warning about this defect. This problem affects up to 1,386 of the instrument arms worldwide.

Heavy Marketing and Promotion

Although this action was classified as a recall, the surgical robots are not being pulled from operating rooms. The da Vinci robot is being promoted heavily by many hospitals nationwide as a cutting-edge surgical technology. This robot is commonly used by many hospitals nationwide for prostate and gallbladder removal as well as for hysterectomy and weight loss surgery. Surgeons can manipulate tiny surgical instruments attached to the robot’s arms using hand controls at a computer system situated a few feet away from the patient. A video camera on one of the robot’s arms provides a view inside the patient’s body.

Reports of Adverse Events

The FDA is currently investigating the increase in the number of problems and adverse events reported with the robotic surgeries, which include injuries, deaths and system malfunctions. According to recent study conducted by Johns Hopkins University’s School of Medicine, between 2007 and 2011, the number of procedures performed with robots increased by more than 400 percent in the United States.

The study also determined that the number of adverse events relating to robotic surgery may have been underreported. Of the one million robotic surgeries performed since 2000, 245 complications, including 71 deaths, were reported to the FDA, a very low number given the number of procedures performed. The Johns Hopkins research team also cited news accounts of incidents that were not reported to the agency until after appearing in the media.

Product Liability Issues

If you have been seriously injured due to a defective medical device, you may have a product liability claim against the manufacturer. Depending on the circumstances of your case, you may also have a claim against the doctor or hospital where you underwent surgery. An experienced California personal injury lawyer will be able to advise you in such cases regarding your legal rights and options.

 

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