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A flood of surgical robots will be entering operating rooms soon. What are the risks?

Posted by John Hadden | Nov 23, 2017 | 0 Comments

According to a recent article in The Economist, robot-assisted surgery is likely to increase in prevalence in coming year. Today, the only robotic device cleared for surgical use in the United States is the Da Vinci Surgical System made by Intuitive Surgical. The device is used to assist surgeons in performing certain procedures including prostate and hernia surgery, hysterectomies, and removal of certain tumors.

However, the Da Vinci is expensive (approximately $2 million) with high maintenance costs, and its uses are limited. As The Economist notes, a number of competitors are seeking to produce cheaper, and more effective, surgical robots. One of the products in developments is the Versius system by Cambridge Medical Robotics. This system consists of independent "arms" that can be placed and configured at the doctor's direction in the operating room. The arms move similar to a human arm, and therefore may be more intuitive for surgeons to use.

Another product in development from Medical Microinstruments, a Pisa, Italy based company, seeks to improve the outcomes of microsurgery, which is important in blood vessel repair as well as procedures performed on premature babies. The device combines small robotic "arms" and "wrists" that attach to tiny surgical instruments with a magnifying instrument that is scaled to the motion of the device and surgeon. In this way, the doctor can manipulate the small body structures with the instrument as if he or she were working on a larger part thanks to the magnification and scaled motion of the device.

Other companies involved in the development of surgical robots are Johnson & Johnson, Medtronic, and Google, along with Da Vinci creator Intuitive Surgical, which is developing a smaller version of the existing device as well as a new device to be used in the treatment of lung cancer.

Despite the promises of surgical robots, risks remain. In an April 2016 article published in PLoS One, "Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data," the authors noted a significant number of complications, including deaths, arising from use of the Da Vinci system. The research indicates a number of incidents involving software or hardware malfunctions, including burned and broken pieces of the equipment falling into a patient, electrical arcing of instruments, unintended operation of the instrument, and video/imaging problems. Scenarios involving a surgical robot may complicate investigation of a medical malpractice case and blur the lines between product liability and professional malpractice. With new medical devices of this type entering the market, there is a significant chance that product liability claims may become an increasing part of medical malpractice cases.

About the Author

John Hadden

John D. Hadden is the owner and founder of the Hadden Law Firm. An experienced trial and appellate lawyer, he is author of three respected treatises on Georgia litigation practice: Greens Georgia Law of Evidence, Georgia Law of Torts - Trial Preparation and Practice, and Georgia Magistrate Court...

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