About the da Vinci Robot

The da Vinci surgical robot was approved by the Food and Drug Administration (FDA) in 2000 and quickly became very popular for use in procedures used to treat uterine fibroids, kidney cancer, prostate problems, endometriosis, obesity, and intrauterine bleeding. The da Vinci system makes surgeries such as hysterectomy and prostate removal easier because the robot is able to make smaller and more precise incisions than can be made by the hand of a human surgeon. Unlike with traditional laparoscopic procedures, da Vinci allows doctors to remotely manipulate robotic arms while observing through a 3D vision system.

Despite a large majority of successful surgical outcomes involving the da Vinci robot, some patients have experienced serious injuries associated with its use. Patients who have been hurt as a direct result of da Vinci surgery can make a report of the adverse event to the FDA.  If the patient experiences injury or if someone loses a family member because of complications with the da Vinci robot, the victim or surviving loved ones may be eligible to take legal action against the manufacturer, Intuitive Surgical.

Serious injuries linked to the da Vinci robot

The da Vinci surgical system was first approved for laparoscopic procedures in 2000 by the FDA and use of the robot has grown by leaps and bounds since that time.  From 2007 to 2011, the number of da Vinci systems increased by 75 percent within the United States.  In 2007, 800 da Vinci robots were installed in hospitals and healthcare centers throughout the U.S., but this number was up to 1,400 by 2011.

The da Vinci robot is frequently used in procedures such as:

• Gastric bypass surgery
• Removal of the uterus, gallbladder or prostate
• Removal of tumors in colon cancer patients
• Bladder surgery

Unfortunately, patients undergoing these and other procedures could experience harm because of alleged problems with the da Vinci robot. According to PBS, researchers studying the da Vinci robotic surgical system over a 12-year-period recently published some disturbing information about patient outcomes in the Journal for Healthcare Quality.  Based on the research, a total of 245 adverse incidents had been reported to the FDA. Of these incidents, 71 people reported that the use of the da Vinci surgical robot had resulted in death. A total of 174 victims experienced injury from da Vinci surgical complications.

These numbers may not accurately reflect the true number of adverse events, as the study found that at least some adverse outcomes were not being reported to the FDA. The researchers stated that reports underrepresented the extent of da Vinci robot injuries in eight cases and that in five cases, no FDA report was filed at all after a problematic outcome.

Some of the complications that have been linked to the robotic system include:

• Muscle damage
• Lacerated organs
• Perforated organs
• Surgical burns
• Blood vessel tearing
• Intestinal tearing
• Burns in the intestines
• Uterine cuts
• Separation of incisions
• Contents of the abdomen expelled through a vaginal opening
• Severe injury to the bowels

Da vinci manufacturer Intuitive Surgical issued a warning to doctors about possible burn injuries in May of 2013, but outside of this warning, little information about these serious and potentially fatal risks was available to patients who were making the choice about whether to undergo surgery with the robot.

da Vinci surgical system advantages and risks

When deciding which surgical approach is the best option for achieving favorable outcomes, patients should be aware of the risks associated with robotic surgery. Several studies show that use of the da Vinci surgical system doesn’t offer tangible benefits in terms of a patient’s care or prognosis.  For example:

• A March of 2012 study in the Journal of Clinical Oncology indicated that there were similar outcomes in terms of morbidity and surgical complications among patients who had traditional hysterectomies as a treatment for endometrial cancer and among patients who had a robotic hysterectomy. Despite the similarities, robotic surgery still cost patients more.
• A January of 2012 study published in the Journal of Clinical Oncology indicated that incontinence and problems with sexual function were about the same after a prostate removal using a surgical robot as compared with a prostate removal using open surgery.
• A 2013 study in JAMA indicated that robotic surgical procedures generally come at higher cost with disproportionately few benefits.

Based on the results of numerous studies, the American Congress of Obstetricians and Gynecologists indicated that there was insufficient conclusive data to suggest that using robotic technology for routine surgical procedures like hysterectomies would improve the outcome for patients.

Injured patients seek legal recourse

According to the available evidence, patients are exposing themselves to potentially life-threatening risks while undergoing da Vinci surgical procedures, while at the same time they may not be receiving any additional benefits compared to traditional surgical procedures.

Individuals who were harmed by the da Vinci surgical system have the right to file a personal injury claim, while those who lost loved ones could take legal action for wrongful death. Dozens of da Vinci robot lawsuits have already been brought against Intuitive Surgical, alleging the system is defective and that the manufacturer negligently failed to warn of the known risks.

Da Vinci surgery injury lawyers are currently investigating claims for possible product liability litigation.

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