Intuitive Surgical, maker of the da Vinci surgical robot, has issued an "urgent medical device notification" alerting hospitals that it has "identified a potential issue" with one of the robot's instruments that can cause internal burns.
According to the notification, obtained by CNBC, "micro-cracks" in some models of Intuitive's monopolar curved scissors can cause leaks that "may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury." The notification added, in bold type: "These micro-cracks may not be visible to the user."
The company issued a statement Friday confirming the notification.
"To date, in over a million surgeries with these instruments, the company has no confirmed evidence of patient injury attributable to this issue," the company said in the statement.