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Intuitive Surgical Warns of Potential Friction Buildup in da Vinci Surgical Robot

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Intuitive Surgical warned doctors this week that friction, in certain circumstances, can form in the arms of some of its $1.5 million da Vinci Surgical System robots, which likely would cause the unit to stall. This marks the second warning from the company about its surgical robot in a month.

Intuitive issued an “urgent medical device recall” November 11 alerting customers to the problem, which impacts 1,386 systems worldwide. The U.S. Food and Drug Administration (FDA) said the stalling can occur during a sudden “catch-up” if the surgeon pushes through the friction-caused resistance, according to Bloomberg News.

A survey by the agency released on November 8 included 11 doctors who have performed between 70 and 600 surgeries using the da Vinci robots. The surgeons reported incidents in which robot arms collided or missed a mark, and said training was an issue.

Intuitive is currently facing mounting questions about its marketing strategies, training procedures, and the safety of the robots. The FDA said last month that the number of adverse event reports tied to the devices had more than doubled this year as of November 3 compared with all of 2012. Intuitive’s third-quarter earnings fell as a result of lower revenue. The company had lost 29 percent of its value in the 12 months through December 3, Bloomberg News reported.

In October, Intuitive sent customers an “urgent medical device correction” warning of potential problems with the metal coating on a lamp that may be incompatible with the control board, according to Bloomberg News.

The da Vinci system was cleared by the FDA in 2000 following a trial of 233 patients at a hospital in Mexico City, Bloomberg News reported.

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