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.”
A statement on the Intuit website dated Nov. 19 says the company is making a “voluntary product correction:”
The company is taking this action after becoming aware that excessive friction within certain instrument arms could interrupt smooth instrument motion, which is felt as resistance by the surgeon. If a surgeon pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position. – See more at: http://intuitivesurgical.com/company/media/statements/2013-11-19-PSM-Correction-statement.html#sthash.UO5bIxUf.dpuf