Da Vinci Surgical System: Risks, Complications & Lawsuit Information

The da Vinci Surgical System is an advanced set of instruments that surgeons use to complete robotic-assisted surgeries. A surgeon performs the surgery by guiding the system’s instruments via a console.

Manufactured by Intuitive Surgical, Inc., the da Vinci Surgical System consists of a:

The system is marketed as minimally invasive and extremely precise, which leads to improved patient outcomes.

Complications with the da Vinci Surgical System are rare but can be severe. Intuitive warns about potential risks, including blood loss as well as inadvertent cuts, tears, punctures and burns. Other injuries to organs, tissues, major blood vessels or nerves are also included on Intuitive’s website.

Device Malfunctions During Surgery

Intuitive reveals that a potential problem with the da Vinci Surgical System is that it may malfunction. Research confirms this issue.

A study published in Urology found that mechanical failure or malfunction occurred in 2.4% of the da Vinci Surgical System procedures they reviewed. Another study in the World Journal of Urology evaluated data from over three million studies that involved the da Vinci Surgical System and found an average malfunction rate of 1%.

Additionally, a 2018 NBC News report revealed there were over 17,000 malfunction reports filed in the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database during the previous 10 years.

Electrical Burns and Thermal Injuries

Multiple patients and their families have reported that the da Vinci Surgical System caused thermal injuries during surgery. Intuitive acknowledges this risk in its safety information.

Patients allege that cracks or slits on the rubber tip that covers da Vinci’s metal instruments allowed electricity to escape and burn patients. A study in the Journal of Eurology supports this, revealing that all da Vinci Surgical System instruments researchers tested showed signs of energy leakage that could potentially cause burns.

Organ Perforation and Internal Damage

There have been incidents of internal damage leading to fatalities during procedures involving the da Vinci Surgical System.

In 2024, Business Insider reported that a woman died after the da Vinci Surgical System allegedly burned and perforated her small intestine. The report revealed that this wasn’t the first time a complication like this occurred.

Other perforations have also been documented. For example, in 2018, an adverse event report was published by the FDA about a bowel perforation that may have occurred during a da Vinci Surgical System procedure. The patient in this report died.

Body Position Injuries

A patient’s body position can contribute to injuries during robotic surgery. A 2013 study found that 6.6% of the urology patients researchers evaluated who underwent robotic surgery had documented body position injuries caused by positioning issues during the operation.

Authors of a 2022 study about robotic-assisted surgeries confirmed this risk, stating that, “Previous studies have demonstrated that positioning injuries do occur and that there is a continues need for increased knowledge and attention to factors that can contribute to positioning injuries.”

One cause of injuries is that some laparoscopic robotic surgeries are performed with the patient in a position called the Trendelenburg. This is when the patient’s body is tilted with the head closer to the floor and the feet higher up. Steep Trendelenburg is routinely used in some robotic surgeries, positioning the patient at a 30 to 40-degree angle.

In traditional laparoscopy, a patient can be moved during surgery to compensate for slipping on the table while in the Trendelenburg position. However, this is not possible during robotic surgery. The robot can’t compensate for changes in the patient’s location on the operating table.

When a patient shifts due to their position on the table during a robotic surgery, it can lead to skin damage and other neuropathic injuries. Shifting can also create tears in incisions, the formation of hernias after surgery and additional postoperative pain related to the stretching of the abdominal wall.

Compression Injuries

Prolonged pressure on a particular body part due to patient positioning during robotic surgery can cause rhabdomyolysis. This syndrome is when muscle fibers break down and their contents are released into the bloodstream.

Rhabdomyolysis is a serious complication that can lead to problems like pain, kidney failure and irregular heart rate.

Face and Eye Risks

The patient’s face, and specifically their eyes, can be injured during robotic surgery if the camera system comes in contact with that part of the body. In some instances, including steep Trendelenburg position, the camera system may be just a few centimeters away from the patient’s face during surgery.

There have been cases of corneal abrasion seen in robotic surgery patients, even when preventative measures were taken to minimize the risks.

Long-Term Patient Outcomes

Some patients have faced long-term complications after da Vinci Surgical System procedures. Ongoing problems can include pain and numbness due to nerve injuries as well as the need for additional surgery to correct perforations.

In addition, some complications have led to patient deaths. There were 144 reported deaths linked to the da Vinci Surgical System from 2000 to 2013.

Complications Compared With Non-Robotic Surgery

There is conflicting data comparing complication rates between robotic and non-robotic surgeries. A 2014 study evaluated robotic and laparoscopic ovary removal surgeries. The overall complication rate was 7.1% for robotically-assisted surgery versus 6% for laparoscopic removal of the ovaries.

However, a 2015 study in JAMA Surgery comparing robotic-assisted versus non-robotic cardiac surgery found significantly fewer complications, shorter hospital stays and fewer deaths for procedures involving robots.

Additionally, a 2022 report in the journal Digital Medicine points to several vulnerabilities that put surgical robots at risk of cyberattack, potentially increasing the risks associated with these types of procedures.

The FDA has an online database of all reports of problems that have occurred called the Manufacturer and User Device Experience (MAUDE). It includes thousands of incidents filed by manufacturers, health care facilities, patients and lawyers related to the use of various da Vinci robotic systems.

In a 2016 study published in PLoS One, researchers looked at 14 years of reports to the FDA at a time when 1.75 million robotic procedures were performed. Between 2000 and 2013, a total of 144 deaths, 1,391 patient injuries and 8,061 device malfunctions were reported with robotic surgery.

Burnt or broken pieces of instruments fell into the patient in 14.7% of the reported cases. Another 10.5% of reports involved electrical arcing of instruments, while 8.6% involved unintended operation of instruments. System errors and video/imaging problems were reported in 5% and 2.6% of the cases, respectively.

More complex surgeries, such as heart, head and neck procedures, had higher numbers of injuries and deaths than surgeries for which robots are used more often, such as gynecological and urological procedures. Surgeons had to wait for the system to restart, or they had to switch to non-robotic techniques or reschedule procedures more than 10% of the time.

“Despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced during procedures,” the authors wrote. “Adoption of advanced techniques in design and operation of robotic surgical systems and enhanced mechanisms for adverse event reporting may reduce these preventable incidents in the future.”

After the FDA’s MAUDE database revealed reports of at least 144 fatalities, 1,391 injuries and 8,061 malfunctions related to the da Vinci Surgical System between 2000 and 2013, FDA actions and safety warnings were issued.

There have also been at least 186 recalls related to the device since 2005, as well as letters sent by Intuitive to customers containing safety notices and suggestions about how to use instruments properly.

Intuitive first received FDA approval for the da Vinci Surgical System to assist with surgeries in 1997. The FDA later approved the system for performing surgeries in 2000. Today, the fifth-generation system, known as the “Da Vinci 5,” is used by surgeons worldwide.

While Intuitive has marketed a revolutionary approach to surgery through this device, there have been many lawsuits related to the injuries and deaths of patients who had da Vinci Surgical System procedures.

Intuitive Surgical, Inc. Marketing Practice

Intuitive boldly marketed its da Vinci Surgical System as superior to other surgical options without evidence to support this claim. Some legal experts argue that this strategy, along with Intuitive’s lack of reporting of adverse effects, pressured hospitals to purchase the system to remain competitive and increase revenues.

The dangers of Intuitive’s marketing strategy were further highlighted in an article published in the Canadian Medical Association Journal. Research found that 73 hospitals that use the da Vinci Surgical System included exact wording from Intuitive’s resource materials.

“None of the informational material had any mention of risks,” Dr. Martin Makary, an associate professor of surgery at Johns Hopkins University School of Medicine, stated in the article. “People tend to view this as the doctor’s voice, when, in many cases, we found the manufacturer authored much of the unsupported claims.”

System Training Concerns

Some surgeons believe Intuitive didn’t provide adequate training for doctors who perform surgery with the da Vinci surgical system. Some surgeons felt that the biggest challenge of using the system was learning how to use it because the user interface is complex.

Research published in Surgical Endoscopy supported this. The study found that, while dry lab training on the da Vinci Surgical System was the generally used approach for training, “focused training on tissue handling, manipulation and force interaction is lacking, despite the absence of haptic feedback.”

Failure to Warn Allegations

Patients, lawyers and even the FDA allege that Intuitive failed to provide adequate warnings about the possible risks of using the da Vinci Surgical System. This was highlighted in the FDA’s 2013 warning letter to Intuitive.

In the letter, the FDA addressed shortcomings in Intuitive’s reporting of adverse events associated with the da Vinci Surgical System. The agency revealed that a lack of reporting could have led to delays in understanding the device’s potential safety issues.

The FDA has acknowledged that, in 2011, Intuitive did send customers a warning about potential issues with the system’s tip covers. However, the device’s manufacturer did not alert regulators to this problem first. Intuitive’s failure to report this warning to regulators broke required procedures.

Intuitive’s response to the FDA’s statement was that the warning it sent “was a reiteration of existing FDA-cleared labeling that reminded users on proper use. The observation is that we didn’t report that we sent the letter. We documented it as a non-reportable field action to the FDA because it did not change any of the FDA cleared labeling.”

Patients are filing lawsuits against Intuitive, seeking compensation for injuries caused by the da Vinci Surgical System’s defects. They also aim to hold the manufacturer accountable for failing to communicate the system’s risks.

Design Defects and Product Liability

Some patients and their families have filed lawsuits claiming the da Vinci Surgical System had design and manufacturing defects.

Lawsuits also claim that Intuitive failed to warn patients and health care providers about the possible risks of using the system during surgery.

Compensation Sought by Plaintiffs

Patients who file da Vinci Surgical System lawsuits are seeking compensation for:

• Current and future medical expenses
• Emotional distress
• Lost wages and future income
• Pain and suffering
• Punitive damages

Additionally, people who have lost a loved one due to the da Vinci Surgical System have filed wrongful death claims to recover medical and funeral expenses as well as the loss of financial assistance, comfort and companionship.

If you’re considering robotic surgery, take the time to compare the potential advantages, like improved precision and shorter recovery times, with the documented risks. This can help you make an informed decision based on your unique situation and risk tolerance.

Talk to your surgeon if you have questions or concerns. They can help you determine the best surgical method for your procedure.

Since its first FDA approval in 1997, the da Vinci Surgical System has been at the center of warnings, recalls and lawsuits.