Rise in Adverse Event Reports Prompts FDA to Investigate da Vinci Surgical Robot

The rising number of adverse event reports (AERs) regarding Intuitive Surgical’s da Vinci Surgical System has prompted the U.S. Food and Drug Administration (FDA) to roll out an investigative survey for surgeons who use the robotic surgical systems during surgery.

AERs increased some 34 percent from 2011 to 2012, rising to 282 from 211. At the same time, the number of da Vinci surgeries also grew, to 367,000 from 292,000, Medscape reported. Some AER’s document major injuries that occurred during robot-assisted surgery, including punctured bladders, severed nerves and blood vessels, and even fatal injuries. Also reported were instances when da Vinci surgical robots seemed to act as if they had a mind of their own, Medscape reported. In some instances, the device, on its own, cauterized a fallopian tube, damaged heart tissue, and refused to let go of a patient’s tissue with its claw.

As for the survey, surgeons were asked about training, common equipment repairs and patient selection. There were questions on how complications stemming from da Vinci-assisted surgeries compared with complications from conventional surgeries. Also discussed: which procedures were the most suitable for da Vinci technology, as well as which were the least suitable.

Robotic surgery has been under investigation from various corners of late. Aside from the FDA’s investigation, back in March the American Congress of Obstetricians and Gynecologists (ACOG) released a statement questioning its effectiveness. As well, health officials from some states are also shining a light on robotic-assisted surgery. Massachusetts, for one, is calling for better training for doctors, as well as greater disclosure of potential risks. The New Hampshire Board of Medicine also has joined the critics.