FDA Scrutinizes Surgical Robots


The many technological advances in medical care have helped many people live longer. In one of the many efforts to improve medical care, the major break-through of robotic surgery was first introduced 12 years ago. These high-precision robots were said to be steadier than the human hand and could operate in smaller spaces than any doctor. It also claimed to produce better and safer medical outcomes for patients as well as less invasive than traditional surgery. However, not all new technology is foolproof.

One doctor in Colorado has been charged by the state’s medical board with unprofessional conduct. The medical board cited complications in 11 robotic surgeries between the years of 2008 and 2010. In one surgery the robot he was using allegedly tore the aorta of a kidney patient. Unfortunately this is not an isolated incident of alleged robotic surgery mistakes.

The Food and Drug Administration (FDA) has announced that it is looking into the increase in serious medical problems and deaths where it is possible that robotic surgery may have had an impact. There are cases of errors could have been caused by the doctor controlling the robotic device and there are also cases where the errors may have resulted from the surgical robot having gone awry. Additionally, in the rare cases where the patient needs to have emergency CPR performed or have an emergency conversion to an open operation, the robot has been in the way.

Incidents that the government is investigating this year include a hysterectomy operation where control of the robotic forceps was lost by the doctor and an operation where the patient’s bowel was torn by the robot. In the second case, emergency surgery was required two days later but unfortunately the patient died.

Despite incidents like the ones mentioned, the number of robotic surgeries has increased significantly, from 25,000 in 2005 to 450,000 in 2012. It is possible that some of the increase in the number of surgeries is the result of doctors utilizing the robots to perform surgeries that may go beyond the machine’s capabilities, the operating surgeon’s capabilities, or both.

In some cases it is believed that robotic surgery may not be any better than conventional surgery. There are differences in the way some surgeries are performed and some procedures may be executed better with robotic surgery while others may not. It is possible that there are only a small number of procedures that give patients a real benefit when performed with the robots. Such surgeries include surgeries that require getting into tighter spaces, such as head or neck surgeries, colorectal procedures, and heart-valve procedures.

Patients injured during surgery, whether or not it was performed with a surgical robot may pursue legal action. If the patient’s injuries can be shown to have resulted from surgical errors, the patient may be able to obtain compensation if they are successful in a medical malpractice claim.

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