Intuitive Robots May Stall in Surgery, Company Warns

Intuitive Robots May Stall in Surgery, Company Warns

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.”

Shares Decline

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.

To contact the reporters on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net; Robert Langreth in New York at rlangreth@bloomberg.net

About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (www.heroinnovator.com), the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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