Healthcare Technology Featured Article

April 22, 2013

Spike in Problems with da Vinci Robotic Surgical Device Attracts FDA Investigation


Robotic surgery, which is being increasingly used in hospitals all over the country for procedures both routine and complex, has many benefits, including increased precision. While humor error is sadly not uncommon in surgeries, leading to complications, injuries and (in some cases) death, it would appear that robotic surgery is not free of issues either – although they, too, may be due to human error.

A number of lawsuits have been filed against Intuitive Surgical, which makes and heavily markets the da Vinci surgical robot. CNBC is presenting a four-part series on the complications, including death, that have resulted from the use of the popular surgical robot. Nearly half a million Americans underwent surgery last year that utilized the $1.45-million DaVinci robot, which is used by nearly one in four hospitals in the U.S.

While most of these procedures were successful, there are some notable cases of catastrophic failures.

According to lawsuits, complaints, interviews with alleged victims, plaintiff attorneys and an FDA database, many of the reported injuries during robotic surgery appear to be burns, and other heat-related damage to intestines, ureter, bowels and other organs from electrical arcing – according to CNBC. Perhaps in an attempt to alleviate the problem, Intuitive Surgical quietly introduced a new instrument tip cover last year and advised hospitals that had purchased the unit to begin using it “immediately,” though the company insists that the change was not made because the part was defectively designed.

Dr. Younes Bakri, director of gynecologic oncology at West Virginia University and a robotic surgeon, recently produced a video that plainly shows continued electrical arcing, even using the new tip cover.

Intuitive Surgical disputes that this is what the video shows, insisting it presents normal operation.

The company declined any further comment on the CNBC article because of pending litigation.

While many clinicians maintain that robotic surgery is safe when performed by a properly trained surgeon, there are others who argue that there simply isn’t enough research to be confident that robotic surgery is as good as – or as safe as – conventional surgery. The da Vinci surgical robot is most commonly used in surgical procedures that involve removing prostates and gallbladders, hysterectomies, repairing heart valves, shrinking stomachs and transplanting organs.

The da Vinci robot is currently the only robotic surgical device that has been cleared by the FDA for use in soft-tissue operations. The agency is now looking into the spate of problematic incidents involved in ordinary use of the system, according to the Associated Press.




Edited by Braden Becker
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