|Intuitive Surgical is working to calm the storm over its da Vinci surgical robot.--Courtesy of Intuitive Surgical|
The swirl of safety concerns over Intuitive Surgical's ($ISRG) da Vinci robot has little merit, the company says, as the recent uptick in reported problems with the device is due to a change in how the company files such things.
Intuitive says it amended its policy back in September, deciding to file minor instrument problems with the FDA and thus increasing the overall number of reported issues with da Vinci. The most common reports involve instrument cable breaks, Intuitive said, which require simple fixes and have resulted in no injuries or deaths.
Similarly, the company changed its categorization of the reports, resulting in more being labeled "serious injury" and fewer dubbed "other," but da Vinci's overall rate of adverse events remains in line with past trends, Intuitive says.
That's all well and good, but even if Intuitive can explain the rise in reports over da Vinci, it remains under the FDA's microscope because of safety concerns with the robot, and the company is still facing at least 10 patient lawsuits claiming da Vinci-caused injuries.
Last month, a study in the Journal of the American Medical Association concluded that da Vinci does little more than add to the cost of surgery, tacking $2,200 to the procedure price without making much of a difference in patient outcomes. Add that to the FDA's piqued interest in the device's adverse events, and Intuitive's cash cow could be in danger.
Robotic surgical devices have taken the market by storm over the past few years, and Intuitive is a leader in the space, notching $2.2 billion in sales last year. But between hospitals eyeing their bottom lines, patients calling their attorneys and the FDA taking a close look at adverse events, da Vinci might not be so lucrative for long.
- read Intuitive's statement