Intuitive Surgical: What's with all the adverse event reports?

October 3, 2013 by Arezu Sarvestani

A harsh Citron Research analysis accuses Intuitive Surgical of ignoring a surge of adverse events associated with the da Vinci robot-assisted surgical system, but the medical device maker says a boost in reporting isn't the same as an increase in incidents.

Intuitive Surgical's graph of the rate of adverse events compared to the rate of reported events since 2010

Analysts at Citron Research published their latest scathing report on embattled Intuitive Surgical (NSDQ:ISRG), citing a surge in reported adverse events that the medical device maker says is a flurry of filings, not a in increase in incidents.

Intuitive Surgical maintained that a closer look at the FDA's MAUDE adverse events database shows a decrease in patient injuries and deaths amid an increase in filed reports over the last 3 years, a company spokesperson told MassDevice.com today.

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"Any assessment of safety trends based on Reporting Dates rather than Event Dates in the MAUDE database will be fundamentally flawed and misleading, and is likely to seriously misrepresent the true performance of a device," according to a company statement.

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