The U.S. Food and Drug Administration (FDA) has received more than 5,000 reports of adverse events associated with the da Vinci robotic system. Most of these reports come from Intuitive Surgical, the maker of the device. They involve cable breaks and minor device malfunctions. However, there are also reports of punctured bladders, bowel perforations, internal burns, and deaths in patients who have undergone da Vinci robotic surgery. The FDA is currently investigating to determine the cause of these injuries.
Some problems have been linked to Intuitive’s instructions to surgeons. Doctors were not initially told that surgical instruments should be cleaned during surgery. So surgeons often scraped the instruments against each other to remove debris. The scraping caused microscopic holes and tears in the protective tip covers on the instruments. This caused electrical leaks that could cause patient burns.
The FDA is also investigating the training that doctors receive before using the robotic surgery system. Most surgeons do their training online. They learn the vocabulary needed to run the machines. Then they practice using the machine on inanimate object. In order to get the training certificate, the doctor must perform a procedure on a cadaver or animal.
Other doctors complete their training in weekend seminars held at teaching hospitals. While doctors are supervised, there are no standards for how many practice procedures must be completed before the doctor performs an unsupervised operation on a human patient.
If you are considering robotic surgery, you should discuss the risks and benefits with your doctor. Ask your doctor about his training and how many procedures he has performed. Find out if there have been any complications. If you feel any doubts, get a second opinion.
The medical device class action attorneys at Hupy and Abraham represent patients in Wisconsin, Illinois and Iowa who have been injured during robot-assisted surgery. To learn more about your rights, please call 800-800-5678.