A major theme of the report relates to the need for improved training of surgeons on the device, in an effort to minimize DaVinci robot failure. While there are critics who rail against the entire concept of robotic surgery and the DaVinci system specifically (together with the increased cost of robot-assisted surgery), there are others who view robotic surgery as safe and effective, provided the surgeon is well-trained and has sufficient experience on the device.
“Training for robotics has been the wild, wild west for a long, long time,” said Jeff Berkley, chief executive of Mimic Technologies Inc., which makes simulators used for robotic training, in comments to Bloomberg News (11/11/13). Hospitals and doctors’ organizations “have to get their act together and start focusing on training,” Berkley added, noting that DaVinci lawsuits are continuing to rise.
Training, as it relates to DaVinci robot failure, is hardly a new issue. While the FDA report highlighting the need for better training was released this month, WNYW FOX 5 New York was on the air seven months ago with comments by its medical contributor Dr. David Samadi, MD, himself a surgeon with vast experience on the DaVinci surgical robot.
“You can’t just go for the weekend and come back, and claim you are a robotic surgeon,” Samadi said in comments on a FOX 5 broadcast in April of this year. “You have to have a program, you have to have the right surgeons, and make sure there is a good credential committee that would sign off,” on these surgeons before they undertake robot-assisted surgery.
Robot-assisted surgery is not new, having been around for 12 years, Samadi said. And while robot-assisted procedures are more expensive than traditional surgery - partly because the hospital needs to recoup the $1.5 million price tag for the DaVinci robot - advocates cite the potential for more precise surgery and better outcomes with the DaVinci, leading to faster recovery times and freeing up beds in the hospital more quickly.
However, the jury is still out on the matter. As the number of robot-assisted surgical procedures rise each year, it appears that adverse event reports are rising in kind. According to Bloomberg, the FDA is reporting 3,697 adverse event reports in the 10 months ending November 3, for this year. That compares with 1,595 reports for all of 2012, according to an FDA official interviewed by Bloomberg. It should be noted that according to a quarterly report filed with the SEC (April, 2013), Intuitive Surgical stated there were 367,000 procedures performed in 2012 with the da Vinci robot--up 26% from the prior year.
Problems have included alleged uncontrolled arcing at the tips of surgical instruments after protective coatings designed to minimize or prevent such arcing has worn away. Other examples of DaVinci Robot injury have allegedly occurred when a portion of the robot inadvertently comes into contact and nicks an organ or tissue - an event that can happen outside of a surgeon’s field of vision, given that he is conducting the surgery with the aid of a high-definition camera. The camera serves as the surgeon’s eyes, and the surgeon sees what the camera sees.
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Dr. Samadi suggested on FOX 5 that a minimum number of procedures whereby a surgeon would be thought to be adequately proficient on the DaVinci robot is about 500. Respondents to the FDA survey, released November 8, reported having performed from 70 to 600 robotic surgeries each using the da Vinci system.
While the respondents agreed the da Vinci robot, overall, led to fewer complications and shorter recovery times, various diverse patient problems were also reported related to operating from injuries. They included reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss, according to Bloomberg.