courtesy: daviddarling
Robotic arms and other robotic mechanisms are increasingly playing an important part in surgery. Many are employed routinely for non invasive surgery or for surgery that requires microscopic vision.
A series of robots, made by Intuitive Surgical, are coming under scrutiny for possible malfunctions.
The FDA has launched a wide ranging study on the side effects and mortality rates that occur when these robotic implements are used, in order to assess if they play a role in higher mortality or more complications in patients that have undergone surgery.
The robots have been used almost 500,000 times last year alone, and the FDA is hard pressed to find out if there are any downsides to its use due to an increasing rate of adverse incident reports.
The study was prompted by reports of several incidents made by both surgeons and patients. But these reports don't give a complete picture of the incidents that might actually be happening.
Some of the reports detail incidents in which serious complications occurred, including gynecological surgeries, which represent about half of all the surgeries done with the aid of robotics. Some of the problems have to do with either rupture of tissues or organs, pieces of the robotics falling from the machines and lodging in the patient's body or burns.
The manufacturer has issued a statement that details how the incidents were, according to their review, caused by improper use of the machines.
A doctor interviewed on the effect of the adverse reports asserts that some of the problems that are occurring might be due to the machine not having a sense of touch, which could transmit any mistakes to the operating doctor, who is usually away from the machine when operating. Therefore in his opinion, injuries could occur because there is no feedback from the machines.
Source: Bloomberg/Langreth 3.2.13
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