In its second warning this month, Intuitive Surgical Inc., the manufacturer of the da Vinci robot surgery system, advised physicians that friction in the arms of some devices might cause unit stalls.
The Urgent Medical Device Recall notice was issued on November 11 and involved 1,386 da Vinci systems across the globe, according to the U.S. Food and Drug Administration (FDA), Bloomberg.com reported. The stalls may lead to a sudden, so-called “catch-up” should the surgeon push through the resistance, according to the FDA.
“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA indicated on its website. “This can be felt by the surgeon as resistance in the movement of the master. In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.” Intuitive company spokeswoman, Angela Wonson, said that Intuitive posted a statement about the recall last month on its website.
In a statement Intuitive issued on November 19th, “there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance.” The firm added that, “No patient complications were reported in association with these three instances.”
Mounting reports of adverse events during robotic surgeries with the Intuitive system have led to increased government scrutiny and a cautionary statement that was recently issued by the American College of Obstetricians and Gynecologists. In its statement, the American College of Obstetricians and Gynecologists wrote, “Robotic surgery is not the only or the best minimally invasive approach to hysterectomy…nor is it the most cost-effective,” according to The Wall Street Journal.
While many tout minimized blood loss, hospital stays, pain medications, and scarring associated with da Vinci surgeries, as well as that the procedures are also less tiring on surgeons, others, including Martin Makary, a pancreatic surgeon at Johns Hopkins, says robotic surgery may be safe and useful for certain procedures, but is gaining too much speed. We have a “culture that marvels at new technology,” says Makary, and a tendency to embrace innovations “without a lot of rigorous, standardized evaluation.” Meanwhile, adverse events tied to the devices are on the rise, the Journal reported.
Some doctors note that hospitals are racing to attract new patients to increase competition, even marketing on billboards and websites, and government officials have expressed concern about oversight, according to the Journal.
A survey by the agency released November 8 involved 11 physicians who performed 70-600 robot surgeries each. The surgeons, who remain unidentified, indicated that the da Vinci led to fewer complications and shorter recoveries, but also reported incidents in which robot arms either collided or missed a surgical mark and noted that training on the device has been an issue, according to Bloomberg.com.