Intuitive Surgical Just Issued an Urgent Medical Notification Over the Da Vinci Robot

Intuitive Surgical Inc., the maker of the da Vinci robotic surgical system has issued an “urgent medical notification” on the controversial device.

The da Vinci has what CNBC described as “a potential issue” with one of the device’s robotic arms, a problem that could burn patients internally, according to StreetInsider.

CNBC just reported that Intuitive has identified “a potential issue” with one of the robotic arms, which could lead to internal burns. The problem is with da Vinci’s EndoWrist Monopolar Curved Scissors, which may develop so-called “micro cracks,” said Intuitive Surgical in the statement. The cracks may not be detectable to the human eye.

The micro cracks could then release electrosurgical energy to patient’s tissues during surgical procedures, which could lead to “thermal injury.” According to Intuitive Surgical, no injuries have been associated with the arms’ micro crack issue; however, six warnings have been issued for the scissors.

In robotic-assisted surgery, a surgeon sits at a console operating several robotic arms that manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the U.S. Food and Drug Administration (FDA) for soft tissue surgeries, such as prostate and gallbladder removal, hysterectomies, heart repair, stomach reduction, and organ transplantation. Other, similar devices have been approved for neurosurgery and orthopedics.

Meanwhile, personal injury lawsuits allege the da Vinci has caused severe internal injuries, including burns, tears, and other complications, some of which resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries. Some 70 deaths have been linked to robotic surgical systems since 2009.

In fact, one case we have been following involves a lawsuit and allegations that a patient’s death was quickened due to a robotic-assisted prostate operation that used the da Vinci system. Physician testimony last week indicated that the complications and stress from the long surgery brought about the man’s death, according to a prior Bloomberg News report. The man might have lived another five years and had a significantly improved quality of life had he never been harmed by botched robotic surgery in 2008, said John S. MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told a jury.

This week, Kate Lederer, of Intuitive, testified that the firm’s training program is adequate and in compliance with a checklist included with what was submitted to the U.S. Food and Drug Administration (FDA) in 2000 when federal approval was being sought for the da Vinci robotic surgical system, wrote Bloomberg News.

Heavily marketed and used in some 400,000 surgeries in 2012 alone, the da Vinci robotic surgery system has been associated with a number of deaths, serious injuries, and odd accidents. For instance, according to a prior Associated Press (AP) report, in one case, a da Vinci robotic hand gripped and would not release a patient’s bodily tissue during surgery. In another, the da Vinci’s robotic arm repeatedly hit a patient in her face as she was prone on the operating table.

In this case, the widow’s allegations include that training was simplified so that more da Vinci’s could be sold and which led to errors in her husband’s prostate surgery. He died of heart disease at age 71 in 2012. Intuitive rebukes those allegations, according to Bloomberg News, and stressed that the surgeon in this case, urologist Scott Bildsten performed 100 successful prostatectomies using traditional surgery. Bildsten never operated unassisted on a patient with the da Vinci system and testified that Intuitive deemed him ready to operate on the da Vinci after just one day of Intuitive training and two supervised surgeries. He said, according to Bloomberg News, that he now realizes he needed to receive more training to perform the unassisted robotic surgery.