Two recalls of more than 100,000 components of Intuitive Surgical’s da Vinci surgical robot have been designated Class II recalls. The U.S. Food and Drug Administration (FDA) just announced that two recalls of more than 100,000 components of Intuitive Surgical’s da Vinci surgical robot have been designated Class II recalls. The FDA describes a Class II recall as a situation in which use of, or exposure to a violative product—in these cases, the da Vinci components—may cause temporary or medically reversible adverse health consequences.
In mid-November, Intuitive advised its customers about the potential for a component in the da Vinci’s Endowrist instrument to detach. According to Intuitive, the recall only impacts devices manufactured prior to October 2011, according to MassDevice.com. The jaw insert in the large needle drivers and mega needle drivers are involved and, wrote Intuitive, “is typically apparent during standard visual inspection or use of the instrument.”
“In most cases, a surgeon would immediately notice if detachment occurred during surgery,” Intuitive also wrote. Dave Rosa, Intuitive’s senior vice president of scientific affairs, told MassDevice.com that Intuitive believes the recall affects about 1,000 units, explaining that the issue involves the brazing between the Endowrists’ tungsten carbide needle driver jaws and the instrument itself. In one case, a re-operation was involved to remove the component, according to Rosa.
Last month Intuitive warned surgeons in an Urgent Medical Device Notification
Last month Intuitive warned surgeons in an Urgent Medical Device notification dated November 11th that friction in the instrument arms could stall during procedures. That recall affected 1,386 of the da Vinci device arms, according to MassDevice.com. The stalls may lead to what the agency described as a sudden, so-called “catch-up” should the surgeon push through the resistance.
Meanwhile, mounting reports of adverse events during robotic surgeries with the da Vinci have led to increased government scrutiny, as well as a cautionary statement recently issued by the American College of Obstetricians and Gynecologists. “Robotic surgery is not the only or the best minimally invasive approach to hysterectomy…nor is it the most cost-effective, the group wrote in its statement, according to a prior The Wall Street Journal report.
Minimized blood loss, hospital stays, pain medications, and scarring have been touted as the benefits associated with da Vinci surgeries, as well as that the procedures are less tiring on surgeons.
But others, for instance, Martin Makary, a pancreatic surgeon at Johns Hopkins, argues that robotic surgery may be safe and in certain cases; however, the technology is gaining too much speed. We have a “culture that marvels at new technology,” says Makary, along with a propensity to adopt innovations “without a lot of rigorous, standardized evaluation.”
Adverse events associated with the surgical robots, are on the rise
Adverse events associated with the surgical robots, are on the rise, The Wall Street Journal reported. In 2004, some 33.3 injury reports per 100,000 procedures were reported and 50 reports per 100,000 procedures were received in 2012. Of the 2012 reports, 28 of the 282 reports involved deaths, up from 34 percent in 2011.
In fact, a draft analysis of adverse event reports written by physicians at Rush University Medical Center, the University of Illinois, and the Massachusetts Institute of Technology, revealed that a significant increase in injury and death rates has been seen concerning robotic surgery.
A 2011 study published in the Journal for Healthcare Quality, and conducted by Johns Hopkins School of Medicine researchers revealed that 164 hospital robot surgery websites surveyed “overestimate benefits, largely ignore risks, and are strongly influenced by the manufacturer,” Bloomberg.com previously reported.