FDA Instigates Probe of Robotic Surgery System


The U.S. Food and Drug Administration (FDA) has begun investigating the safety of  the da Vinci robotic surgical system manufactured by Intuitive Surgical Inc.

Bloomberg News writes that the investigation of the da Vinci system and related robotic products raises questions about the prospects of one of the hottest technologies in health care. The robots cost about $1.5-$2.2 million each and, last year, were used in almost half a million surgical procedures.

The FDA is surveying surgeons at hospitals that belong to its product safety network, asking them to list complications they may have encountered with the machines.  The survey also asks the doctors to discuss their training with the system and to indicate which surgeries the robots might be most and least suited for, according to copies of the survey obtained by Bloomberg News.

The agency is trying to determine whether a rise in incident reports submitted to the FDA are “a true reflection of problems” with the robots, or the result of other issues, Synim Rivers, an agency spokeswoman, told Bloomberg News in an email. Incident reports are sent to the agency by patients, medical professionals, and companies. Many of the reports about the da Vinci were filed by Intuitive Surgical and these state that no robot malfunction was found or that the problem came from user error. Several reports originated from patients.

In robotic surgery, the physician, using hand and foot controls, operates surgical tools from a console several feet from the patient. A camera provides a three dimensional view of the work being done inside the patient. Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore, told Bloomberg News in a telephone interview that “The Achilles-heel feature” of the robot is its lack of tactile feedback, which can spur “inadvertent injuries if added caution is not taken.”

Surgeons have been debating whether the benefits of robotic surgery justify the increased costs, Bloomberg News writes. For example, according to a report published in the Journal of the American Medical Association on February 20, hysterectomies performed robotically cost hospitals $2,189 more than hysterectomy surgery performed without the robot, without reducing complications.