Analysts Warn of Rising da Vinci Surgical Robot Injury ReportsOct 4, 2013
Pointing to an increase in reports of adverse events, Citron Research has taken critical aim at Intuitive Surgical, maker of the da Vinci surgical robot.
Citron analysts issued a report in which they scold Intuitive and other analysts for underestimating issues that, according to Citron, have fueled a drop of about one-third in the device maker’s shares since this time last year, according to MassDevice.com.
Through one lens, it has been a challenging year for Intuitive Surgical. The U.S. Food and Drug Administration (FDA) targeted the company with an investigation into surgical complication rates tied to the da Vinci surgical robot. Also in recent months: the American Congress of Obstetricians & Gynecologists issued a statement that questioned the benefits of da Vinci robotic surgery; a high-profile lawsuit accused the company of aggressive marketing practices; the device maker issued a warning concerning cracks in instruments attached to the surgical robot; and shareholders’ brought a class action lawsuit against Intuitive and its executives.
Citron analysts have warned that recent headlines critical of Intuitive and its da Vinci surgical robot are part of a bigger problem, and that the device maker is “not investable til it gets its house in order," reported MassDevice.com. Citron is urging Intuitive to accept responsibility and handle the "surprising" rise in adverse events and deaths reported this year.
"In the 1st 8 months of 2013, 2,332 Adverse Event records were posted—compared to 4,603 records posted in the entire 12-year period since the 1st Adverse Event tracking for da Vinci appeared in MAUDE [Manufacturer and User Facility Device Experience] in 2000," Citron wrote, according to MassDevice.com. "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."
Intuitive Surgical spokeswoman Angela Wonson denied that a true increase in da Vinci incidents has even occurred. Citron looked at the reporting and not the occurrence dates, she said, noting that although the reporting has increased, incidents have actually decreased, MassDevice.com reported.
The FDA has criticized Intuitive for its failure to properly disclose measures it took to protect patients from accidental electrical burns caused by a flaw in the da Vinci, MedScape Medical News reported, citing a May 30 FDA report based on inspections in April and May.
Personal injury lawsuits filed against the da Vinci allege severe internal injuries, including burns, tears, and other complications, with some procedures allegedly causing chronic pain, disability, or death. Lawsuits typically mention Intuitive’s aggressive marketing tactics and allege that design flaws inherent in the robot, combined with poor training on the device for physicians, are to blame for the injury and harm resulting from some da Vinci procedures. Some 89 deaths have been associated with the da Vinci surgical robot since 2009.