Da Vinci Robot Surgery: Legal Information and Lawsuits

Since their debut in the 1980s, robotically assisted surgeries have become increasingly common. In a robotically assisted procedure, a surgeon uses a robot to manipulate surgical instruments. This allows for more precise control of incision and removal.

Robots reduce a surgeon’s stress and fatigue, especially during longer operations. In addition, the robotic arms are remarkably steady. This allegedly helps reduce patient recovery times and potential surgical errors.

Intuitive Surgical introduced the da Vinci surgical system in 2000. This was when the U.S. Food and Drug Administration (FDA) approved the medical device. It quickly became a popular robotic device. Today, more than 1,400 hospitals in the U.S. use da Vinci systems. Doctors have used these robotic surgery devices in millions of procedures.

But recent reports of mechanical complications resulting from robotic procedures are a concern. Patient injuries have caused heightened scrutiny of the da Vinci surgical robot.

This article describes the health risks of the da Vinci robot surgery system. It also discusses the history of Da Vinci robot surgery lawsuits. You’ll also learn how to pursue a product liability lawsuit against the medical device manufacturer.

Medical device companies have a legal responsibility to ensure their products are free of defects and carry adequate warnings. If you’ve been harmed by a surgical robot, an attorney near you can help you navigate your product liability claim.

How Does Da Vinci Robotic Surgery Work?

The da Vinci Surgical System uses several mechanical arms and a nearby console. Surgeons use its high-definition, three-dimensional system and state-of-the-art instruments to operate on a patient’s body. These features offer several advantages:

• Using mechanical arms removes the risk of a trembling human hand missing its mark
• The view system offers a clear line of sight to the operating area
• Surgeons are less fatigued by lengthy surgeries

Intuitive Surgical claims these features make surgeries less invasive, resulting in less blood loss and shorter recovery periods.

Due to its viewing system and mechanical arms, medical professionals often use surgical robots for procedures in small, hard-to-reach areas. Surgeons frequently use the da Vinci Surgical System for the following procedures:

• Hysterectomies
• Gallbladder removals
• Heart surgery
• Weight loss surgeries
• Organ transplants
• Minimally invasive surgeries
• Hernia repair
• Fibroid removal
• Colorectal procedures
• Urologic procedures

Doctors use these devices in urology and general surgery as well. For example, some estimate that surgeons use robots in 85% of all prostate removal surgeries. Future uses of surgical robots may include treating cancer in the head and neck.

Injuries Caused by Da Vinci Surgical Robots

The FDA monitors reports of medical device problems, including injuries and malfunctions related to robotic surgery and other medical devices. The FDA tracks this information in its MAUDE system.

Common mechanical problems of Intuitive Surgical Inc.’s da Vinci surgical robots reportedly include:

• Malfunctioning arms
• Control freezes
• Electrical problems
• Sparking

In some cases, technicians have to restart the surgical systems during surgery. Many times, surgeons have had to switch to hands-on surgical procedures when surgical robots malfunction. This increases the patient’s chance of developing an infection.

Common patient injuries reportedly include:

• Organ and tissue punctures
• Infections
• Electrical burns
• Breathing problems
• Shoulder pain
• Internal scarring
• Pain and nerve damage
• Bleeding

Also, the recovery time for robotic surgery tends to be as long or longer than traditional surgeries.

Da Vinci Surgical Robot Problems and FDA Warnings

Thousands of patients have reported adverse events after having minimally invasive surgery. As a result, many of these patients have filed personal injury lawsuits against Intuitive Surgical.

The various claims plaintiffs have made against the manufacturer include:

• Robotic systems latch on to patient tissue, causing perforations and other damage
• Faulty surgical tips cause burns and injury to organs and tissue
• Improper suture of vaginal cuffs during hysterectomies

In extreme cases, some da Vinci robots have committed fatal mistakes during surgical procedures, leading to severe injuries and even death.

When the FDA learned about these risks, it sent a warning letter to Intuitive at its headquarters in Sunnyvale, California. The 2013 letter criticized Intuitive’s safety notification procedures. According to the FDA, Intuitive failed to report many da Vinci surgical system malfunctions.

The FDA also criticized the company for failing to include instructions on how to clean da Vinci’s robotic instruments. Improper cleaning can damage the robots and expose patients to dangerous germs and infections.

Robotic Surgery and Product Liability

According to the Securities and Exchange Commission, Intuitive Surgical cited 93 lawsuits in its 2014 financial reports. As of mid-2014, the company had set aside more than $77 million to settle pending cases.

By 2018, the number of adverse events involving Intuitive’s da Vinci Robotic Surgery system increased to more than 20,000. More than 2,000 of these reports involved severe injuries. Another 274 reported the death of a patient as a result of issues with the surgical system.

Many of these reports involved a problem with the device’s insulation. Many patients filed product liability cases against Intuitive, alleging that its da Vinci surgical device caused severe burns and other injuries.

According to the plaintiffs, these insulation problems cause electrical currents to leak from the device into patients’ bodies. This leakage caused severe burns. In some cases, patients died from these burn injuries.

In 2022, a Florida man named Harvey Sultzer sued Intuitive for wrongful death. His wife Sandra underwent surgery for her colon cancer in September 2021. The electrical currents leaking from the defective device burned her small intestines. Her injuries were so severe she passed away in February 2022.

Under product liability, you must show that you suffered an injury due to a defective product. Your product liability attorney must demonstrate that the product was unsafe and that the product manufacturer failed to warn about its product’s risks.

In a da Vinci robotic surgery case, a plaintiff must show that they suffered an injury due to a defect in the surgical device. They must also demonstrate that Intuitive Surgical didn’t warn them about the device’s potential risks.

Robotic Surgery and Medical Malpractice

Patients injured by the da Vinci robotic system may also file a medical malpractice lawsuit. It depends on the circumstances. Under medical malpractice law, doctors and hospitals may be liable for damages if they act negligently.

With the da Vinci robotic surgery lawsuits, patients may claim that their surgeon wasn’t adequately trained on how to use the device. They can also argue that the hospital or surgical facility didn’t properly clean and maintain the system. If they can prove that these acts led to patient injuries, they may be able to collect damages.

Another way a doctor can be liable for medical malpractice is if they fail to warn their patient about the risks associated with the surgical device.

If you can prove any of the above, you may recover damages. Some of these include:

• Medical bills
• Future medical expenses
• Lost wages
• Lost future income
• Pain and suffering
• Emotional distress
• Punitive damages

It’s worth noting that judges rarely award punitive damages in these cases. Your attorney would have to prove that the defendant behaved recklessly or intentionally. This isn’t easy to prove.

Robotic Surgery and Wrongful Death

People who have lost a close relative to a da Vinci surgical system malfunction may file a wrongful death lawsuit against Intuitive. Under wrongful death laws, family members may sue the party responsible for their loved one’s death.

In a successful wrongful death lawsuit, relatives may recover compensation for the following:

• Medical and funeral expenses
• The loss of the deceased’s financial assistance
• The loss of comfort and companionship

An Attorney Can Help With Your Da Vinci Robot Surgery Lawsuit

Filing a da Vinci injury lawsuit is complex, often requiring medical evidence, expert witnesses, and a detailed knowledge of product liability law. This is why it’s best to consult an attorney experienced with medical device cases before deciding on a course of action.

You may need painful corrective surgeries if you suffered harm during a da Vinci procedure. You’ll also get large medical bills. A product liability lawsuit can help you receive compensation for these bills. Your attorney can also demand compensation for lost wages, future income, and pain and suffering.

FindLaw’s directory of product liability attorneys can connect you with local legal help who can help secure a favorable verdict. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with medical device litigation.