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WHO IS RESPONSIBLE FOR COMPLICATIONS IN ROBOT-ASSISTED SURGERY?

Robot-Assisted Surgery Introduces New Complications

The rapid advance of technology has changed the way we carry out our daily lives. Every aspect of modern life shows impact from recent discoveries and inventions, and one area where this change is strongly evident is in the field of medicine. In 2000, the FDA approved the use of robotic systems to help surgeons treat their patients. Robot-assisted surgery, sometimes called RAS, claims a number of promised benefits, including shorter hospital stays, less bleeding, and faster recovery to normal life when compared to similar procedures performed without the robotic assistance. When things go wrong, however, who should be held responsible?

Mechanical Concerns

Last month, Mercury News ran a report looking at the scope of product-liability cases against the da Vinci system – currently the only FDA-approved robotic surgical system on the market. Intuitive Surgical, a company that manufactures da Vinci, stated in 2014 that they were looking at 3,000 such cases spanning 2004-2013 – a period in which their machines were involved in 1.7 million procedures. Many early cases involved malfunctioning parts of the system that were then recalled by the company. While the company is still dealing with a number of cases, many of them date back to 2012 or 2013. The company has settled in most cases, with only two going to trial and a third scheduled for June. None of this has scared away investors, who have doubled the company’s stock price since late 2015. This may be related to the low incidence of problems being mechanical in nature.

Human Factors

Dr. Dwight Chen told Mercury News, “The robot doesn’t make a bad surgeon a good surgeon. The robot actually enhances what you can do. But if you’re a bad surgeon, you’re still going to be a bad surgeon with a robot.” This concern is explored in more detail by the Patient Safety Network, who reported that while damage from robot malfunction has a relatively high chance of being permanent, the actual rate of injury from malfunction is only approximately 0.1%-0.5%. The authors of that article place their concerns primarily on the surgeons operating the robotic systems. They note a lack of universal standard guidelines for surgeons to be trained or certified to perform RAS, and a poor system for reporting and penalizing surgical errors using robots. Importantly, they also found that RAS shows no considerable long-term benefit over non-robotic procedures, and the introduction of a mechanical element to surgeries actually creates new chances for complication that are not being adequately explained to patients. In fact, the article cites, “Kaushik and colleagues found that less than 70% of patients were appropriately counseled preoperatively on the potential risks specific to robotic surgery.”

We at Deratany & Kosner agree that these concerns need to be addressed. Victims of surgical errors deserve to be heard, especially if there is not an adequate means to consistently report their case. If you or a loved one has been injured through RAS, or were not provided with enough information to make a knowledgeable choice, tell us your story so we can help you and pursue the justice you deserve.

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