Intuitive Surgical Ignored da Vinci Adverse Events: Report

Intuitive Surgical faced a harsh analysis in a whitepaper from Citron Research. In the paper, researchers at Citron accused the company of ignoring adverse events associated with its robotic surgical system, dubbed da Vinci. In response, the medical device manufacturer states that an increase in adverse event reporting is not the same thing as an increase in the number of adverse events.According to Intuitive Surgical, a rigorous look at its FDA MAUDE entries shows that there has been a drop in patient injury and mortality associated with the da Vinci surgical system over the past 36 months."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," notes the company.For its part, analysts at Citron Research believe that the company has underestimated concerns that have dragged down shares of the company by approximately one-third over the past 12 months. Some recent issues at Intuitive include a shareholder class action lawsuit, a surgical instrument crack warning, a patient-injury lawsuit that alleges the company engaged in aggressive legal actions, an unfavorable statement from the American Congress of Obstetricians & Gynecologists and an FDA probe into high numbers of complications.Citron analysts believe that these issues could signal severe underlying problems at the company. Analysts at the firm stated that the company is "not investable til it gets its house in order." On top of this, analysts at Citron called for the company to take a strong stance against the high number of deaths and adverse events reported so far this year. "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," noted Citron. "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."Angela Wonson, a spokesperson for Intuitive Surgical, denied this claim, stating that Citron analysts focused on the date that an event was reported instead of focusing on when the event took place."Understanding this Reporting Date/Event Date disconnect is particularly important if a quantity of adverse event notifications are received in a short timeframe - e.g., if a news story, Internet posting, or advertising or legal campaign generates a sudden flurry of claims," stated a spokesperson for Intuitive. The statement continued, "In such a situation, a batch of reports covering the adverse events would be submitted to the FDA, and the resulting MAUDE data would exhibit a surge in entries clustered around a recent reporting date. However, the underlying events may have occurred over a much longer period of time, and therefore the data would not be indicative of a sudden increase in adverse events."In its response, Intuitive Surgical conducted an analysis of MAUDE reports associated with its robotic surgical system. However, both researchers and regulators warn that this isn't a credible way to track the rate of incidences.In its conclusion, Intuitive stated that the actual number of incidents have decreased in recent years. However, the perceived uptick in adverse events is due to more rigorous reporting.