Comprehensive training and robust data crucial to robotic surgical safety

December 16, 2015

Since the da Vinci Surgery System was granted FDA approval in 2000, robotic surgery has become commonplace within hospitals and health systems, offering a new pathway for minimally invasive surgery for specialties like urology and cardiology. Although surgeons and hospitals have extolled the system's benefits, a lack of robust data has left some wondering if robotic surgery is safer than traditional surgery, and more specifically, how mechanical and operator errors can lead to patient injury or death.

A recent retrospective study, conducted by researchers at the University of Illinois at Urbana-Champaign, the Massachusetts Institute of Technology, and Rush University Medical Center, analyzed adverse events reported to the FDA from 2000 to 2013. During that time period, 144 deaths were linked to robotic surgeries, along with nearly 1,400 injuries. Additionally, the FDA database contained more than 8,000 reports of device malfunctions, including:

  • Burned or broken instrument pieces falling into the patient
  • Electrical arcing (or discharge)
  • Unintended operation of instruments
  • System errors
  • Video imaging problems

The malfunctions forced surgeons to interrupt the surgery to restart the system, abandon the robot in favor of traditional surgical techniques, or reschedule the surgery for another time. In some cases, they led to injuries.

Continue reading this article on the Patient Safety Monitor website. Subscribers have free access to this article in the December issue.