The FDA says the recall of more than 100,000 components of Intuitive Surgical's da Vinci surgical robot is Class II, meaning the products might cause a temporary health problem or pose only a slight threat of serious consequences.
Intuitive notified customers Nov. 15 of the potential for a component in the da Vinci's Endowrist instrument to detatch, saying the problem only affects devices made before October 2011 and that most of the affected products are not in use. The problem involves the jaw insert in Intuitive's large needle drivers and mega needle drivers and "is typically apparent during standard visual inspection or use of the instrument," according to a press release.
"In most cases, a surgeon would immediately notice if detachment occurred during surgery," Intuitive said in a Nov. 19 statement. "The reported occurrence rate of jaw insert detachment is 0.01% per procedure."