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Late News: Inquiries into da Vinci rise
But system claims 'no increase' in adverse events

By Jaimy Lee
Posted: March 2, 2013 - 12:01 am ET

The maker of the popular da Vinci robotic surgery system is playing defense as federal regulators, noting an increase in adverse events associated with the technology, queried surgeons who use it.

“There has been no increase in the rates of adverse events or death for da Vinci Surgery,” a spokeswoman for Intuitive Surgical said in a statement. “The clinical evidence shows that da Vinci is safer than open surgical alternatives in many of the common procedures in which it is used.”

In January, the Food and Drug Administration sent a survey to hospitals that participate in the FDA's medical product safety network. The survey is voluntary and will collect confidential information from surgeons about their perspectives on the challenges of using the da Vinci Surgical System.

“The survey is intended to help us better understand these users' perspectives on the different challenges raised when using the da Vinci system interface for performing surgery versus using conventional surgical procedures and also to assess current and future trends in robotic surgery,” an FDA spokeswoman said in an e-mail.

The agency also said it wanted to clarify whether the boost in the number of adverse events reflects problems with the technology or rather can be attributed to more awareness among clinicians to report adverse events. The questions provided to the hospitals were not available.

Nearly 1,900 da Vinci Surgical Systems have been installed at hospitals in the U.S., as of Dec. 31, 2012, according to the company's most recent financial filings. Intuitive Surgical said that procedure volume in the U.S. grew to 367,000 in 2012, compared with 292,000 in 2011, and overall growth was driven in part by gynecologic and general surgery procedures in the U.S.

Some researchers have raised questions about the costs of robotic technology. The system itself has a price range of $1 million to $2.3 million.

A study published last month in the Journal of the American Medical Association found that robotically assisted hysterectomy for benign gynecologic disorders had “substantially higher costs” than laparoscopic hysterectomy, which has a similar morbidity profile.


The FDA wants to know if the boost in the number of adverse events reflects issues with the technology or the awareness among clinicians to report adverse events.



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