FDA Announces Class II Recall On da Vinci Surgical Robot Systems
July 23rd, 2013|
July 23, 2013
The U.S. Food and Drug Administration (FDA) recently announced the Class II recall of Intuitive Surgical’s da Vinci Surgical System robots. Records show that 30 of the units may not have been properly tested before being received for use by customers.
The devices have been lauded as a technological breakthrough in surgical procedures because it allows surgeons to perform delicate procedures in a more efficient and less invasive manner. Complaints have been filed though, saying that the device may not be safe.
Some patients have experienced serious burns and other injuries that were either caused by a malfunction in the machine or by doctor’s error. At least 70 deaths have been associated with the use of the robot since 2009.
Now, the FDA has launched the da Vinci Surgical Robot Recall after several parts were determined to have not met the testing standards established by the FDA. According to an article from Bloomberg News, this was the result of a data recorder failing to take note of testing results.
Those who are in possession of an affected unit have been contacted by Intuitive to have corrective action taken with the machine. Any adverse events associated with the use of an affected device should be reported to the FDA immediately.
The Defective Medical Device Attorneys with Ferrer, Poirot & Wansbrough are here to answer any questions an individual may have if they were the victim of a botched procedure using the da Vinci Surgical System.