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.
Surgical Robot Complications
- Five deaths have been linked to the robotic surgical system.
- Reports of the robot’s hand not letting go of tissue grasped during surgery have been documented.
- One patient got hit in the face by the robot’s arm while she was lying on the operating table.
- More than 500 da Vinci incidents have been reported by the FDA since January 2012.
- The Huffington Post reports the following incidents filled just this year:
- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
- A Chicago man who died in 2007 after spleen surgery.
- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci’s maker filed that report after seeing a newspaper article about it and said the doctor’s office declined to provide additional information.
- A robotic arm that wouldn’t let go of tissue grasped during colorectal surgery on Jan. 14. “We had to do a total system shutdown to get the grasper to open its jaws,” said the report filed by the hospital. The report said the patient was not injured.
- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
Nearly 400,000 Da Vinci Surgeries Preformed Last Year
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:
- Gastric bypasses
- Gall bladder removal
- Thyroid cancer surgeries
- Cardiac operations
- Head and neck procedures
FDA Investigates Da Vinci
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.
Surgeons Only Required One Day of Robotic Training
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.
Questions for your Surgeon
There are always risks involved with surgery, but you can be better prepared by asking your doctor the following questions.
- How were you trained?
- When did you do your first da Vinci procedure?
- How many robot assisted operations have you done?
- How often do you do them?
- What will you do if the robot malfunctions during the operation?
- Will you be training another surgeon during the procedure? If so, will he or she be performing any portion of the surgery?
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