INTUITIVE SURGICAL ROBOTS PROBED BY U.S. REGULATORS
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Thamanna Hussain
Our firm has been investigating and filing suits on behalf of robotic surgery patients over the last year, and there is now developing news which reports the concerns we have been seeing. Intuitive Surgical Inc., the supplier of robots used in surgery, is the subject of a safety probe for its products by U.S. regulators. According to Robert Langreth who is reporting this matter for Bloomberg News, regulators surveyed doctors to discuss their training and list any complications they may have seen with Intuitive's robots. Through this survey, the U.S Food and Drug Administration( FDA) is trying to establish whether adverse incident reports sent to the agency are actually a true indication of problems with the robots, or the outcome of other factors.
The reports to the FDA outline serious complications, including gynecological surgeries that created damages to the uterus as well as when certain instruments broke off from the robot and actually fell into a patient. Reports also concluded that there were burns to a number of organs or vessels. In the past, these reports serve as an early warning system on concerns about medical devices. Bloomberg news also stated that the Achilles-heel feature of the robot is its lack of tangible feedback which can surge inadvertent injuries, if there is no added caution.