Adverse events associated with Intuitive Surgical's da Vinci robot have been "vastly underreported," according to Johns Hopkins researchers who culled news reports and court records to identify unreported complications associated with the surgical system.
The da Vinci robotic surgery system—which typically costs between $1.5 million and $2.5 million and is used in more than 1,400 hospitals nationwide—allows surgeons to perform procedures using hand controls at a computer system several feet away from the patient. It has been on the market for more than a decade, and more than one million procedures have been performed using the robot.
According to the study, published in the Journal for Healthcare Quality, thousands of mishaps related to the robotic surgical equipment were reported to FDA between 2000 and 2012. Most of those events did not cause patients harm; 71 of the mishaps resulted in death, and another 174 caused a patient injury.
However, news reports and court documents identified botched operations that were not reported to FDA, according to the study. The findings suggest that many cases of complications associated with the robot may not be reported to the agency.
Is reporting just the 'tip of the iceberg'?
Diana Zuckerman, the president of the National Research Center for Women and Families, said it is widely accepted that FDA reporting represents just "the tip of the iceberg" of surgical complications and adverse reactions. As a result, devices continue to be widely marketed to consumers, despite a poor understanding of the injuries that the equipment may cause.
Angela Wonson—Intuitive's vice president of corporate communications—said the study "gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the FDA." Rather, Intuitive takes incident reporting "very seriously" and makes "every effort to account for all reportable events—even those from several years prior."
Broader problems for Intuitive
The latest study follows a series of critical reports about robot-assisted surgery, Roni Caryn Rabin writes in the New York Times "Well" blog. A series of lawsuits against Intuitive has shed light on "aggressive tactics" that the company uses to market the equipment and cast doubt on the quality of training provided to surgeons, Rabin writes.
Nonetheless, use of the robot has risen dramatically across the United States; the number of procedures performed using da Vinci has increased by more than 400% from 2007 to 2011. This expansion has occurred without proper evaluation and monitoring of the benefits, says lead study author Martin Makary.
"This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do," he says, adding, "We adopt expensive new technologies, but we don't even know what we’re getting for our money—if it's of good value or harmful."
Makary says part of the issue is FDA's reporting mandate, which "has no teeth." Instead, "[W]e have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement and no consequences," he argues, adding that it is up to FDA to "figure out whether this is a problem related to the device or a doctor error" (Rabin, "Well," New York Times, 9/9; Cooper et al., Journal for Healthcare Quality, 8/27 [subscription required]).
The Advisory Board's take
Rachel Klein, Technology Insights
By focusing on the robot, the New York Times lets the surgeon off the hook a bit too quickly—the robot is a tool, just like anything else.
Surgical mishaps could be due to any number of factors, including surgeon skill and training, poor visualization, complex anatomy, or robot malfunction. If this was a laparoscopic case, the story probably wouldn't have made headlines. But since the robot was involved it's a big story, which I'm not sure is an accurate representation of the cause of injury.
Here's what I'd take away: For relatively unskilled surgeons who advocate for the da Vinci, robotic surgery isn't a substitute for broader surgical training and oversight. The robot makes doing some minimally invasive cases easier, but doesn't mean that the surgery does not carry risks.
Overall, there are definitely reasons to not invest or invest in the robot (higher cost [and] unclear clinical benefit relative to the standard, among other reasons) but I'm not yet convinced that device malfunction is one of them.
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