Citron puts Intuitive Surgical on blast over adverse events

October 7, 2013 by Arezu Sarvestani

Intuitive Surgical defends its adverse event reports, which analysts at Citron Group call a 'gross misuse of statistical data.'

Citron puts Intuitive Surgical on blast over adverse events

The battle between surgical devices maker Intuitive Surgical (NSDQ:ISRG) and analysts at Citron Group continues to heat up, with harsh words from one and a stern defense from the other.

Citron Group today issued an open letter to Intuitive Surgical, accusing the company of misusing FDA data to falsely paint a picture of declining adverse events associated with the da Vinci surgical robot.

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Both companies have ceded that the FDA's MAUDE adverse event reporting system is flawed at best, and the FDA itself has warned against using the database to attempt to infer a device's safety profile, but a recent surge of patient injury and death reports associated with Intuitive's flagship da Vinci system has raised a few eyebrows.

""In the 1st 8 months of 2013, 2332 Adverse Event records were posted – compare to 4603 records posted in the entire 12 year period since the 1st Adverse Event tracking for da Vinci  appeared in MAUDE in 2000," Citron wrote. "It is the opinion of Citron that the only reason there is not a national outcry is because the da Vinci robot has yet to kill or injure 'the right person' – like the next of kin of a congress member or a celebrity."

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