da Vinci surgical system

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Robotic Arm Troubles: Possible Stall During Surgery, Company Says

We’ve written about the aggressive marketing of robotic surgery systems and doctors questioning the benefits of such surgery for certain operations, like hysterectomies.

SwedishMedicalCenter/flickr

SwedishMedicalCenter/flickr

Now come warnings about possible stalling in the da Vinci robotic surgery system, which is manufactured by Intuit.

Bloomberg reports:

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. Continue reading