Intuitive Surgical Inc. (ISRG), the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.
The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the U.S. Food and Drug Administration said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.
Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported. The FDA said last month that the number of adverse event reports, including deaths, injuries and system malfunctions, has more than doubled this year as of Nov. 3 compared with all of 2012.
“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA said on its website. “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’s sales and share price have taken a hit this year. On Oct. 17, the Sunnyvale, California-based company reported a decline in third-quarter earnings as a result of lower revenue. Intuitive fell less than 1 percent to $370.68 at the close today in New York. The company has lost 24 percent of its value this year.
Intuitive posted a statement about the recall on its website last month, Angela Wonson, a company spokeswoman, said today in an e-mail.
Out of more than 55,000 operations completed 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 said in the statement dated Nov. 19. “No patient complications were reported in association with these three instances.”
Bloomberg first reported in February that the FDA was looking into the challenges surgeons face with the robotic systems, first cleared by the agency in 2000 after a trial of 233 patients done at a hospital in Mexico City.
A survey by the agency released Nov. 8 included 11 doctors who have performed from 70 to 600 robot surgeries each. While the unidentified surgeons said the device led to fewer complications and shorter recoveries, they reported incidents in which robot arms collided or missed a mark and said training was an issue.
In October, the company sent an “urgent medical device correction” letter to users warning of potential problems with metal coating on a lamp that may not be compatible with the control board.
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