FDA Gives da Vinci Surgery Robot a Closer Look after Deaths

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Reports of da Vinci robot surgery complications, including death from excessive bleeding, prompt FDA investigation.

The da Vinci robot, commonly used by doctors in operating rooms across the country to help perform robotic surgery, is now being given a closer look by the U.S. Food & Drug Administration after an increase in reports of severe complications such as nicks and cuts to internal organs, excessive bleeding and death.

In 2012, the da Vinci robot was used in almost 400,000 surgeries throughout the country, a number that has tripled since 2008. It is now used in almost 1,400 hospitals in the United States for robotic hysterectomy, robotic prostatectomy and other surgeries.  The da Vinci robot is also often seen as a selling point for hospitals as many feature the technology on their websites and even on billboards

There are several benefits of da Vinci surgery that surgeons cite over traditional laparoscopic surgery, such as smaller incisions and the ability to sit down during surgery to avoid becoming tired after standing for long hours. The medical robot hands are also considered much more stable than a human hand, which can shake during surgery. Patients also reported having quicker recovery times.

But some doctors are now saying that the enthusiasm for the medical robot may have been a bit premature.

The FDA began to see a spike in the number of reports of da Vinci surgery complications. In early 2013, the federal agency began a survey of doctors who use the machines to look into the matter further.

According to FDA spokeswoman Synim Rivers, it is unclear what has caused the increase in reports — whether its the increase in the number of da Vinci robots being used or if its an increase in the awareness of doctors that accidents need to be reported. Rivers also noted that it’s the responsibility of da Vinci maker Intuitive Surgical Inc. to report problems, not necessarily the doctors.

According to reports, there have been at least five deaths due to problems with da Vinci surgery complications. In 2012, a woman died during a robotic hysterectomy when a blood vessel was accidentally nicked by the machine. A man died in 2007 while having his spleen removed. The man’s family won $7.5 million in 2012 as part of a da Vinci robot lawsuit settlement, after they alleged their family member  died because it was the surgeon’s first robotic surgery. The surgeon claimed that the da Vinci was not the cause of death.

According to Dr. Martin Makary, a Johns Hopkins surgeon who took part in research of the da Vinci robot, adverse side effects of robotic surgery are underreported.

“The rapid adoption of robotic surgery . . . has been done by and large without the proper evaluation,” Makary said.

Many of the lawsuits concerning robotic surgery have to do with the experience or lack of training of the surgeon. Other da Vinci robot lawsuits place the blame on Intuitive Surgical.

An essay published in the New England Journal of Medicine in 2010 recommended that doctors do 150 procedures before they are considered adequately trained on robotic surgery.

If you or someone you know was severely injured while undergoing da Vinci surgery, legal options are available. Learn more and get a free consultation regarding a claim’s eligibility at the Da Vinci Robot Surgery Class Action Lawsuit Investigation. Experienced legal professionals will contact you and guide you through the appropriate steps if you qualify.