Safety and Robotic Surgery

January 1, 2013 | Evaluations & Guidance


In this Guidance Article on surgical robotics, we highlight the only robotic surgery system currently on the market: Intuitive Surgical’s da Vinci Surgical System. As with most healthcare products, there have been several safety issues involving this system. Since the da Vinci’s introduction, ECRI Institute’s Health Devices Alertshas published 25 product safety alerts involving both the system and its consumables. We have also learned of problems through our discussions with users. Examples of capital equipment problems include issues with the brakes that hold the robotic arms in place, surgical control issues (e.g., loss of surgeon control of system components), and software problems (e.g., crashes). Examples of problems with consumables include mislabeling, missing or defective parts, and problems that prevent optimum sterility or protection of accessories. We’re also aware of user-error incidents involving problems such as cutting, burning, and perforating the wrong pieces of tissue/organs. Note that these aren’t necessarily ongoing problems; many have been resolved. But they give a sense of the kinds of issues that can affect the da Vinci system.

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