The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon’s capabilities and offer a state-of-the-art minimally invasive option for major surgery. The robot typically costs about $1.5 million and issued in more than 1,300 hospitals nationwide.  With the da Vinci Surgical System, surgeons operate through just a few small incisions. The da Vinci System features a magnified 3D high-definition vision system and tiny wristed instruments that bend and rotate far greater than the human wrist. As a result, da Vinci enables your surgeon to operate with enhanced vision, precision, and control.

Minimally invasive da Vinci Surgery uses the latest in surgical and robotics technologies.  It is typically used in cancer surgery, hysterectomies, and gallbladder removals.  Although it is called a robot, the surgeon is 100% in control of the da Vinci System.  The da Vinci System has brought minimally invasive surgery to more than 2.5 million patients worldwide.

In 2013, the FDA warned the da Vinci manufacturer, Intuitive, about robot safety.  The main warning regarding a potential defect in the robot’s surgical scissors.  According to Bloomberg reports, at this time, the company lost about $6 billion in value.   The company also received warning letters from the FDA criticizing the company’s safety-notification process.  An FDA inspection in April and May of 2013 uncovered a number of deficiencies, including a failure to adequately report device corrections.

Intuitive took corrective actions and in April, 2014 an FDA compliance officer informed them that the company’s corrective actions in response to the FDA’s warnings were adequate.  As of March 31, 2014 da Vinci systems installed throughout the United States rose to 2116.  The number of surgeries rose from roughly 367,000 in 2012 to 422,000 in 2013.

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