- What are Computer-Assisted Surgical Systems?
- Common uses of Robotically-Assisted Surgical (RAS) Devices
- Recommendations for Patients and Health Care Providers about Robotically-Assisted Surgery
- FDA Activities
- Additional Resources
Different types of computer-assisted surgical systems can be used for pre-operative planning, surgical navigation and to assist in performing surgical procedures. Robotically-assisted surgical (RAS) devices are one type of computer-assisted surgical system. Sometimes referred to as robotic surgery, RAS 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 a RAS device may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body. The device is not actually a robot because it cannot perform surgery without direct human control.
RAS devices generally have several components, which may include a:
- Console: Where the surgeon sits during surgery. The console is the control center of the device and allows the surgeon to view the surgical field through a 3-Dimensional endoscope and control movement of the surgical instruments;
- Bedside cart: Includes three or four hinged mechanical arms, camera (endoscope) and surgical instruments that the surgeon controls during surgical procedures;
- Separate cart: Contains supporting hardware and software components, such as an electrosurgical unit (ESU), suction/irrigation pumps, and light source for the endoscope.
Most surgeons use multiple surgical instruments and accessories with the RAS device, such as scalpels, forceps, graspers, dissectors, cautery, scissors, retractors and suction irrigators.
The FDA has cleared RAS devices 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 RAS devices are gall-bladder removal, hysterectomy and prostatectomy (removal of the prostate).
While robotically-assisted surgery is safe and effective for performing certain procedures when used appropriately and with proper training, the FDA has not granted marketing authorization for any robotically-assisted surgical device system for use in the United States specifically for the prevention or treatment of cancer.
Robotically-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 robotically-assisted surgeries, as well as the risks and benefits of other treatment options.
Patients who are considering treatment with robotically-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.
Health Care Providers:
Robotically-assisted surgery is safe and effective for performing certain procedures when used appropriately and with proper training. The FDA regulates devices to provide reasonable assurance of their safety and effectiveness for their intended uses. For RAS devices, this includes assuring manufacturers implement adequate training programs for both new and experienced users. The FDA does not supervise or provide accreditation for physician training nor does it oversee training and education related to legally marketed medical devices. Instead, the development and implementation of training 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 RAS devices should ensure surgeons are trained properly and have appropriate credentials to perform surgical procedures with these devices. Device users should ensure they maintain their credentialing. Hospitals and facilities should also ensure that other surgical staff who use these devices complete proper training.
Users of the device should realize there are several different models of RAS devices. 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 RAS devices, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the 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.
1. Why did the FDA update the February 28, 2019 Safety Communication?
The FDA has become aware of continued use of Robotically-Assisted Surgical (RAS) devices for the prevention of cancer and treatment of patients with cancer. It is important for health care providers and patients to understand that the FDA has not granted marketing authorization for any RAS devices specifically for the prevention or treatment of cancer.
2. Are RAS devices permitted to be used in patients who have cancer?
The FDA regulates medical devices and generally does not regulate the practice of medicine within a health care practitioner-patient relationship. The FDA has evaluated and cleared RAS devices for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up. The safety and effectiveness of RAS devices for the prevention and treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival have not been established.
3. What is known about using RAS devices to perform mastectomy procedures for the prevention and treatment of breast cancer?
There is little evidence on the safety and effectiveness of the use of RAS devices in patients undergoing mastectomy for the prevention or treatment of breast cancer, and the FDA has not granted any RAS device marketing authorization for mastectomy. For patients undergoing mastectomy, the surgical approach used with RAS devices differs from conventional surgical approaches. The impact of these differences on prevention of cancer, overall survival, recurrence, and disease-free survival have not been established.
4. What is known about using RAS devices for the treatment of cervical cancer?
We are aware of limited reports that conclude that minimally invasive surgery (which included laparoscopic surgery or surgery using RAS devices) was associated with a lower rate of long-term survival compared with open abdominal surgery. Other reports have demonstrated no significant difference in long-term survival when these types of surgical procedures are compared. Clinicians and patients should be aware of this information when making treatment decisions.
- The FDA continues to receive and analyze medical device reports (MDRs) related to robotically-assisted surgical devices. The majority of the medical device reports that the FDA receives are of device malfunctions, such as component breakage, mechanical problems and image or display issues. Generally these reports are not associated with injuries. However, the FDA has received reports of injuries and deaths related to RAS devices. The FDA receives mandatory reports from device manufacturers, device user facilities, and importers, and voluntary reports from health care professionals, patients, caregivers and consumers. These multiple sources can lead to duplications and inaccuracies. Because reports submitted to the FDA can also contain incomplete, inaccurate, or unverified information, confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. The submission of a report to the FDA does not necessarily indicate a faulty or defective medical device.
- The FDA also continues to evaluate information on RAS devices from other sources, such as published studies and case histories, in addition to the reports described above. Monitoring the safety and effectiveness of medical devices relies on multiple sources of information to inform decisions about a device’s safety and effectiveness.
- To obtain additional information, the FDA conducted a small sample Medical Product Safety Network (MedSun) survey of experienced surgeons who use robotically-assisted surgical devices 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 encourages academic and research institutions, professional societies, RAS device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Such real-world evidence may help characterize surgeons' learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety. However, clinical studies to determine the safety and effectiveness of RAS devices for unapproved uses such as the treatment of cancer, including when a registry infrastructure is used to collect the clinical study data, must be done under an IDE.
- 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 RAS devices to better understand the risks and benefits. The FDA will keep the public informed if significant new information becomes available.
- UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication
- Caution When Using Robotically-Assisted Surgical Devices in Women’s Health Including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication
- November 2013 Medical Product Safety Network (MedSun) Small Sample Survey - Final Report for the da Vinci Surgical System (PDF - 134KB)