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.
As part of the notification, the company (ISRG) included a list of six Precautions and Warnings for Usage of the EndoWrist Monopolar Curved Scissors.
The safety of the da Vinci, including an increase in reports of injury involving robotic surgery, was the focus of the recent CNBC Investigations Inc. documentary, the Da Vinci Debate , and an article on CNBC.com .
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