Intuitive Surgical Inc., maker of the da Vinci surgical robot system, reports its revenues fell the most in three months after third-quarter profit declined on lower sales of the da Vinci and related equipment.
Revenue decreased 7.2 percent to $499 million. Intuitive sold 101 da Vinci systems, for about $1.5 million each, compared with 155 for the same period a year ago, Bloomberg News reports. Industry analysts who follow Intuitive had estimated earnings of $525.9 million this quarter.
Intuitive has faced intense scrutiny over its marketing practices and the safety and cost effectiveness of the da Vinci system in light of increasing reports of patient injuries, complications, and deaths. Earlier this year, the U.S. Food and Drug Administration (FDA) began to survey surgeons about their experiences with the robot system, including questions about their dealings with Intuitive. In July, the agency sent Intuitive a warning letter after an inspection revealed that the company hadn’t adequately reported product corrections and some patient adverse events, according to Bloomberg News.
Though robotic surgeries haven’t been evaluated through randomized trials to determine their benefits compared with standard procedures, more than 350,000 robot-assisted surgeries were performed in U.S. hospitals last year, Bloomberg News reports. The robot is most commonly used in hysterectomies, gall bladder removals, prostate cancer treatment, and other soft tissue operations, often replacing accepted minimally invasive techniques without evidence of better outcomes. The robot systems can add to the cost of the surgery: the Journal of the American Medical Association reported that robotic hysterectomy costs about $2,000 more than hysterectomy performed without the robot.
Adverse event reports, including as many as 70 deaths, have risen steadily since 2009. Alleged complications include burns and/or tears of the intestines, punctured blood vessels or ureters, bowel injuries, and excessive bleeding. Plaintiffs in a number of lawsuits filed against Intuitive Surgical allege their surgeons received insufficient training before using the robots unassisted. Surgeon training has been shortened and simplified from the process given in the company’s FDA device-approval application.