Dangerous medical device attorneys like me have been keeping watch on surgical robots, a new technology used in certain kinds of surgery. Promoters of the robots say they make surgery easier on patients by requiring smaller incisions, and thus less blood loss and faster healing. But reports of serious problems with surgical robots have also arisen, saying they can accidentally cut patients and cause dangerous or deadly bleeding. That’s why I was interested to see a report from Bloomberg News saying Intuitive Surgical’s da Vinci surgical robots are being recalled because of a tendency of the robotic arm to stall during surgery, which can lead to injuries if the surgeon attempts to push through the arm’s physical resistance. It’s the second warning in a month about the robots.
According to the article, the robots can stall because there’s friction in the arms of some of the robots—1,386 of them across the world. The surgeon using the robot feels this as resistance. If the surgeon pushes through the resistance, the machine will suddenly catch up to the indicated position. This can cause problems if it creates a movement the surgeon didn’t intend. Intuitive Surgical issued an urgent recall of those robots Nov. 11, which the U.S. Food and Drug Administration noted Dec. 3. The prior recall, sent in October, had to do with a metal coating on the unit’s lamp that is not compatible with the control board. An FDA inspection earlier in 2013 found that Intuitive had not reported certain safety changes it had made to its robots.
The FDA inspection was motivated in part by the fact that reports of adverse events are on the rise. According to the Wall Street Journal, the FDA received about 50 adverse event reports per 100,000 surgeries in 2012, up sharply from 13.3 per 100,000 in 2004. In real numbers, 2012 saw 28 death reports and more than 250 injuries. The article said “horror stories” from da Vinci robot surgeries include accidental punctures, tears, burns or even heavy bleeding from a cut artery. In fact, the article said, Intuitive is facing about 50 defective medical device lawsuits from people who suffered injuries or lost loved ones during robotic surgery. A jury in Oregon recently awarded a woman more than 110,500 after she sued over a surgery with a malfunctioning da Vinci robot that left several foreign objects inside her body.
These surgical robots are not as widespread as ordinary surgery, of course, but it’s clear that they’ve been catching on. That’s disturbing, because the evidence suggests that there are safety problems with these robots. The manufacturer says there were no patient complications connected to the recalled robots. But an FDA survey found that doctors noticed problems like arms colliding during surgery, and also wanted better training. That comports with the Bloomberg report suggesting that some people are starting to question Intuitive’s training for doctors, as well as its marketing practices. Under those circumstances, I’m pleased that the FDA is keeping a close watch on surgical robots, and that the pending robotic surgery injury lawsuits may shed light on their safety.