The da Vinci surgical robot has been used in operating rooms around the U.S. for more than a decade. But after hundreds of complications – some fatal – the U.S. Food and Drug Administration is now investigating.
The da Vinci robot is often beloved by surgeons for its ability to perform precise and complex operations in a minimally invasive way. Nearly 1 out of 4 U.S. hospitals have at least one da Vinci system. That is almost 1,400 hospitals.
According to da Vinci’s maker, Intuitive Surgical Inc., the number of robotic surgeries has risen from 114,000 in 2008 to 367,000 in 2012. That is triple the number in just four years.
Most often this type of high tech surgical system is used for prostatectomies (prostate removals) and hysterectomies. However, it is increasingly being used other operations such as:
Earlier this year, the FDA decided it would conduct a survey of surgeons using the robotic equipment to hopefully be able to answer growing concerns.
The reason for the study now “is the increase in number of reports received” about Da Vinci, said FDA spokeswoman Synim Rivers.
A surgeon is required a relatively minimal amount of training to operate this state-of-the-art technology.
This is partly because when da Vinci was first approved by the FDA in 2000 it was done so through a process called “premarket notification,” often used to permit medical devices to be used without the typical rigorous testing required of new drugs.
Before da Vinci was cleared for market, the FDA asked Intuitive twice for more details into how surgeons would be trained to use the technology. The robot makers informed them of their 70-item exam and three-day hands-on training protocol.
Only a couple years later, in 2002, Intuitive decided to decrease the amount of required training by replacing the 70-item exam with a 10-question online quiz. The company also reduced the amount of hands-on training from three days to only one.
There are always risks involved with surgery, but you can be better prepared by asking your doctor the following questions.
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