What does this news mean for providers? The Advisory Board's Rachel Klein weighs in.
Intuitive Surgical last month issued a warning that devices used in its robotic surgery system may momentarily stall during procedures and endanger patients, FDA reported in a notice this week.
The agency classified the issue as a Class II recall, meaning that Intuitive's da Vinci robot could cause "temporary or medically reversible" health problems, with a remote potential for serious complications.
The system allows surgeons to perform minimally invasive procedures—such as a prostate removal—using hand controls at a computer system located several feet away. Each da Vinci system typically has three to four robotic arms.
The notice states, "Reports of friction within certain instrument arms can interrupt smooth instrument motion," adding, "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 sent an "urgent medical device recall" to alert its customers of the problem, which affects 1,386 instrument arms sold worldwide.
Under the microscope
Of more than 55,000 operations performed with the affected instruments, "there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance," the company says, noting that "[n]o patient complications were reported in association with these three instances."
The devices are not being recalled from the market. However, Intuitive has urged customers to inform their surgeons about the matter and schedule inspections of the devices for repairs or replacements. According to company spokesperson Angela Wonson, nearly 70% of the inspections are complete, and only a "minimal" number of robotic systems required adjustment.
Problems grow as shares decline
The Wall Street Journal's Joseph Walker reports that the warning is the latest in a series of problems for Intuitive this year. Last month, FDA reported that the number of adverse event reports associated with the robot—including deaths, injuries, and system malfunctions—has more than doubled this year as of Nov. 3, compared with the entirety of 2012.
Intuitive has also faced increasing scrutiny about its marketing strategies and training procedures. An FDA survey of 11 doctors who each had performed 70 to 600 robotic surgeries found that the device led to fewer complications and shorter recoveries. However, the doctors reported incidents in which robot arms collided or missed their mark; they also noted that adequate training was an issue (Intuitive release, 11/19; Pettypiece/Langreth, Bloomberg, 12/4; Walker, Wall Street Journal, 12/4).
Note: An earlier version of this article incorrectly stated that nearly 1,400 da Vinci systems were affected by the recall.
The Advisory Board's Take
Rachel Klein, Technology Insights
The latest news on robotic instruments stalling during procedures extends Intuitive's year of bad luck—FDA recalls, lawsuits, negative depictions in academic journals and popular news sources, and finally, plummeting sales and stock value.
However, we do not think that this recall will affect many hospital programs.
In our work with hospitals that own da Vinci robots, we have rarely come across incidences of equipment malfunction, much less issues that caused patient harm. (Editor's note: See more context from Rachel on how to understand the da Vinci debate.)
That said, these kinds of high-profile incidents may cause patients to perceive robots as unsafe, unpredictable instruments that are likely to experience more problems in the future. In turn, hospital administrators who are on the fence about whether continuing to grow robotic programs is a clinically justifiable and cost-effective strategy may take this as one more reason to avoid purchasing another robot for their program.
If concerns about the robot continue to build, sales may continue to decline or remain stagnant. However, what may be an even greater driver of declining sales is the saturated domestic market, with over 2,000 installs in the U.S. currently. We anticipate that Intuitive may shift its growth strategy to the global arena, especially if the U.S. audience is increasingly jaded about the benefits of robotic surgery.