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U.S. Department of Health and Human Services

Medical Devices

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Computer-Assisted (Robotic) Surgical Systems

What are Computer-Assisted (Robotic) Surgical Systems?

Different types of computer-assisted surgical systems can be used for pre-operative planning, surgical navigation and to assist in performing procedures. One type is computer-assisted surgical systems, commonly called robotic-assisted surgical systems or robotic surgery.

These medical devices enable the surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (minimally invasive) for a variety of surgical procedures. The benefits of computer-assisted surgical systems can include the device’s ability to facilitate minimally invasive surgery and assist with complex tasks in areas of the body that may be difficult to navigate, as well as shorter post-operative recovery times. The device is not actually a robot because it cannot perform surgery without direct human control.

Computer-assisted surgical systems generally have several components, which may include:

  • A console, where the surgeon sits during surgery. The console is the control center of the system and allows the surgeon to view the surgical field and control movement of the surgical instruments and the camera (endoscope) though a 3D monitor;
  • The bedside cart that includes three or four hinged mechanical arms, camera (endoscope) and surgical instruments that the surgeon controls the during surgical procedures; and
  • A separate cart that contains supporting hardware and software components, such as an electrical surgical unit (ESU), suction/irrigation pumps, and light source for the endoscope.

Most surgeons use multiple surgical instruments and accessories with the computer-assisted surgical system, such as scalpels, forceps, graspers, dissectors, cautery, scissors, retractors and suction irrigators.

Common uses of Computer-Assisted Surgical Systems

The FDA has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general surgery cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. Some common procedures that may involve computer-assisted surgical systems are gall-bladder removal, hysterectomy and prostatectomy (removal of the prostate).

Recommendations for Patients and Health Care Providers about Computer-Assisted Surgical Systems:

Health Care Providers:

Computer-assisted surgery is an important treatment option that is safe and effective when used appropriately and with proper training. The FDA does not regulate the practice of medicine and therefore does not supervise or provide accreditation for physician training nor does it oversee training and education related to legally marketed medical devices. Instead, training development and implementation is the responsibility of the manufacturer, physicians, and health care facilities. In some cases, professional societies and specialty board certification organizations may also develop and support training for their specialty physicians. Specialty boards also maintain certification status of their specialty physicians.

Physicians, hospitals and facilities that use computer-assisted surgical systems should ensure that proper training is completed and that surgeons are appropriately credentialed. Device users should ensure they maintain their credentialing. Hospitals and facilities should also ensure that other surgical staff that use these devices complete proper training.

Users of the device should realize that there are several different models of computer-assisted surgical systems. Each model may operate differently and may not have the same functions. Users should know the differences between the models and make sure to get appropriate training on each model.

If you suspect a problem or complications associated with the use of computer-assisted surgical systems, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Patients:

Computer-assisted surgery is an important treatment option but may not be appropriate in all situations. Talk to your physician about the risks and benefits of computer-assisted surgeries, as well as the risks and benefits of other treatment options.

Patients who are considering treatment with computer-assisted surgeries should discuss the options for these devices with their health care provider, and feel free to inquire about their surgeon’s training and experience with these devices.

FDA Activities:

  • The FDA is aware of an increase in the number of medical device reports (MDRs)  related to computer-assisted surgical systems. The majority of the medical device reports the FDA received were of device malfunctions, such as component breakage, mechanical problems and image/display issues. However, the FDA has also received reports of injuries and deaths related to the device. This increase in reports may be due to a number of factors, including an increase in the number of devices being used or surgeries being conducted,  better awareness of how to report device issues to the FDA, increased publicity resulting from product recalls, media coverage, and litigation, as well as other influences.  In addition, because reports submitted to the FDA can contain incomplete, inaccurate, duplicative, and unverified information, confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. For these reasons, the FDA also evaluates other information to make decisions about a device’s safety and effectiveness, relying  on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices.  MDRs of suspected device-associated deaths, serious injuries and malfunctions are one of these sources, but submission of a report to FDA does not necessarily indicate a faulty or defective medical device.   
  • To obtain additional information, the FDA conducted a small sample Medical Product Safety Network (MedSun) survey of experienced surgeons who use computer-assisted surgical systems in a variety of procedures. The goal was to better understand the user’s perspectives and the different challenges identified when using this type of system to perform surgery compared to conventional surgical procedures.
  • The FDA is working with professional societies to encourage training and education associated with the use of these devices.
  • The FDA routinely monitors postmarket performance of marketed devices and inspects manufacturing facilities that make the medical devices, and will continue to collect and analyze all available information regarding computer-assisted surgical systems to better understand the risks and benefits. The FDA will keep the public informed if new information becomes available.
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