“Intuitive Surgical Inc. (ISRG), the maker of robotic surgical devices, fell in extended trading after it disclosed a Food and Drug Administration warning letter and reduced its sales forecast.
The company received the warning letter July 17, Chief Executive Officer Gary Guthart said during a conference call with analysts to discuss quarterly earnings. FDA inspections in April and May found a number of deficiencies, including that the Sunnyvale, California-based company in some cases hadn’t adequately reported device corrections and patient adverse events, according to a report dated May 30.
Safety and cost effectiveness of the company’s da Vinci robot devices have been under scrutiny. Bloomberg News reported in February that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009.
Guthart said the agency is asking for additional steps to resolve two of the observations in the inspection report.
“We believe these issues are addressable and will continue to work with the FDA to ensure this is resolved to their satisfaction,” Angela Wonson, a company spokeswoman, said in an e-mail after the call.
Intuitive’s robotic surgery system, used in more than 1,300 hospitals, is the company’s primary product and has been the subject of negligence lawsuits alleging that patients were injured during surgeries with the device. Cancer surgery, hysterectomies and gall bladder removals are among the procedures conducted with the robot, which costs about $1.5 million each.”
“Intuitive Surgical, which until the first quarter had been accustomed for several years to ever-surging demand for its robots and procedures, said business was also being hurt by “negative press.” That was a reference to recent media reports questioning the cost effectiveness of the costly robotic procedures.”
As documented on this site, the company has profited from years of breathless, gee-whiz news coverage. If you’re going to play the manipulate-the-media-for-marketing game, you may stand to gain something, but you may stand to lose something. Tradeoffs. Just like with the use of the technology itself. Some of the chickens may be coming home to roost.
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