Patients and families in major cities like Denver may be concerned about another warning issued by Intuitive Surgical Inc. in December 2013. The fabricator of the $1.5 million robot surgical operating system warns that the device stalling could result in a surgical error due to friction in the arms of certain devices. The initial urgent medical device recall was first issued in November 2013, warning that the defect may affect more than 1,380 devices around the world.
On the Dec. 3, 2013, the Food and Drug Administration posted on its website that stalling can occur if surgeons attempted to push through resistance while operating. According to Bloomberg News, Intuitive Surgical Inc. is now facing questions regarding its marketing campaigns, training protocols and the safety of its devices. The FDA also noted that by Nov. 3, 2013, the count of adverse reports regarding system malfunctions, injuries or deaths had already exceeded double the total during 2012.
Stock for Intuitive Surgical Inc. has declined by 24 percent throughout 2013. In an email, a spokesperson for Intuitive said that there have been 55,000 surgeries completed with the effected robotic instruments. So far there has been one report of an imprecise cut made due to the interrupted motion of the robotic system. There were also two other reported instances of practitioners experiencing perceived resistance. There were no complications for the patients in these three reports.
Surveyed doctors that conducted 70 to 600 robotic surgeries said that training was an issue and that the mechanical arms either missed the target or collided with each other on multiple occasions. Many patients and families often feel clueless or helpless after learning that a surgical error has occurred. Local attorneys may be able to help people who think they may have been wronged. An attorney could investigate whether they have a viable malpractice case and are due restitution for potential damages.
Source: Bloomberg, “Intuitive Robots May Stall in Surgery, Company Warns”, Shannon Pettypiece, Robert Langreth, December 04, 2013