Risks Associated with Robotic Surgery
Years ago, it seemed like science fiction — using robots to perform surgery. Now robot surgery has become a reality. Yet just how safe is it?
According to Bloomberg News’ recent review of informal incident reports sent to U.S. regulators, since 2009 at least 70 deaths have been linked to robot systems made by Intuitive Surgical Inc., which is based in California. There have been at least 10 lawsuits, including at least one products liability lawsuit, filed against Intuitive in the last 14 months.
So exactly how does robotic surgery work? Robotic surgery is different from other minimally invasive surgery, where the doctor stands over the patient and manually manipulates the instruments and camera. Instead, the doctor sits a video-game-like console several feet from the patient and looks into a high-definition display. He or she uses hand controls and foot pedals to maneuver the mechanical arms, which are equipped with tools. A 3-D camera guides the doctor, showing the work as it is completed inside the patient.
The number of adverse incident reports to the Food and Drug Administration has increased since 2009. Injury reports increased from 24 in 2009 to 115 in 2012. Deaths increased from 11 to 30 during the same time period. These reports, however; do not necessarily mean that the robots caused the deaths, only that they were involved in the procedures in which death occurred. Intuitive has denied the claims in the lawsuits, and it remains confident that its robots are “extremely safe.”