The safety of robots made by Intuitive Surgical Inc. (ISRG) is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.
The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training, according to copies of the survey obtained by Bloomberg News.
via Intuitive Robot Probe Threatens Trend-Setting Surgeries – Bloomberg.
Bloomberg has reported that The FDA has inquired into complications resulting during robotic surgery. I believe this inquiry is targeted towards gynecologic surgery.
I have been involved with robotic surgery for 9 years and have seen many different instruments and different robotic platforms (davinci, davinci S, davinci Si). There is inherent risk in any surgical procedure, whether surgery is performed robotically, laparoscopically, or with an open incision. I believe an experienced surgeon and team can lead to lower complication rates and I do feel that robotic surgery is inherently safer in that it has a lower complication rate in my personal experience at least.