New Report Links Robotic Surgery to 144 Deaths Since 2000
A team of researchers from MIT, Rush University Medical Center, and the University of Illinois Urbana-Champaign have published a paper on Adverse Events in Robotic Surgery, which takes a look at the causes and patient impacts of surgical adverse events in an effort to improve operational systems and practices in the future. After reviewing more than 10,000 incident reports of robotic surgeries from the FDA from 2000 to 2013, researchers found 1,391 patient injuries and 144 patient deaths with 500 error reports per 100,000 surgical procedures.
The team of researchers set out to do a comprehensive study of the safety and reliability of robotic surgeries given the fact that their use has been increasing significantly. Between 2007 and 2013 there have been 1.7 million robotic surgical procedures performed in the United States, with most of them being performed in urology and gynecology. The highest number of deaths occurred in the more complex surgeries such as cardio thoracic and head and neck procedures.
The report indicates that during the study period there were 8061 device malfunctions which included:
- The falling of burnt and broken pieces of instruments into the patients
- Electrical arcing of instruments
- Unintended operation of instruments
- System errors
- Video/ imaging errors
What does the Food and Drug Administration have to say about robotic assisted surgery?
While the FDA has cleared robotic assisted surgery (RAS) devices for use by trained physicians in an operating room environment, they do not regulate the practice of medicine. The FDA does not have any jurisdiction over physician accreditation, training or credentials. It is the responsibility of doctors and hospitals that use RAS devices to ensure that surgeons are properly trained and have the credentials to operate these devices.
The FDA is aware of the incidents of injuries and deaths related to the use of RAS devices, and it states that the submission of a medical device report (MDR) does not necessarily indicate a faulty or defective medical device.
The FDA advises patients that robotic surgery may not be appropriate in all situations. Patients should speak to their doctor about the benefits and risks of RAS and other treatment options. They should also ask about their surgeon level of experience and training using a robotic assisted surgical device prior to surgery.
Christopher T. Nace works in all practice areas of the firm, including medical malpractice, birth injury, drug and product liability, motor vehicle accidents, wrongful death, and other negligence and personal injury matters.
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