Surgical Robot Injuries: Da Vinci, Mako & Robotic Surgery Complications

When you agree to robotic surgery, you are placing enormous trust in both your surgeon and the technology they use. Robotic-assisted procedures are often presented as safer, more precise, and less invasive than traditional surgery. For many patients, that promise holds true. But when something goes wrong with a surgical robot, the consequences can be devastating -- prolonged recovery, additional surgeries, permanent organ damage, or worse.

If you or a loved one suffered unexpected complications during a robotic-assisted procedure, you are not alone, and you may have legal options. These cases sit at the intersection of medical malpractice and product liability law, and determining who is responsible requires careful analysis of what happened during your surgery.

Common Surgical Robot Complications

The majority of robotic-assisted surgeries in the United States are performed using the da Vinci Surgical System, manufactured by Intuitive Surgical. By early 2026, the da Vinci system had been used in more than 20 million procedures worldwide and is cleared by the FDA for use in urological, gynecological, cardiothoracic, and general surgical procedures. While the system has a strong safety record overall, serious complications have been documented.

da Vinci System Injuries

Reported complications associated with the da Vinci system include:

Electrical arcing and thermal burns: The system's electrosurgical instruments can produce unintended electrical arcing, causing burns to surrounding tissue and organs. These burns may not be immediately apparent during surgery and can lead to delayed perforation or infection.
Organ and tissue perforation: Unintended punctures to the bowel, blood vessels, ureters, or other organs during instrument insertion or manipulation. Perforations can result in internal bleeding, sepsis, and the need for emergency open surgery.
Uncontrolled instrument movement: Reports exist of robotic arms moving unexpectedly or failing to respond to surgeon commands, potentially striking or damaging tissue outside the intended surgical field.
Mechanical and system failures: Component malfunctions, including broken instrument tips left inside patients, camera failures during critical moments, and software errors requiring mid-procedure system restarts.
Conversion to open surgery: When robotic complications occur mid-procedure, surgeons may need to convert to open surgery, significantly increasing recovery time, scarring, and risk of infection.

Hugo RAS System and Other Platforms

The Hugo Robotic-Assisted Surgery (RAS) system, developed by Medtronic, is a newer entrant to the surgical robotics market. The Hugo system received CE marking in Europe and is commercially available in over 30 countries. It received FDA clearance in December 2025 for urologic surgical procedures. As with any newer medical device, the long-term safety profile is still being established. Other surgical robot platforms, including the Senhance system (originally developed by Sofar SPA, later marketed by Asensus Surgical, now owned by Karl Storz) and the Versius system (CMR Surgical), are also being adopted in hospitals. Patients injured during procedures using any robotic surgical system may have grounds for a legal claim.

Surgical Robot Adverse Events by the Numbers

The scope of surgical robot complications is broader than many patients realize. The FDA maintains the Manufacturer and User Facility Device Experience (MAUDE) database, which collects reports of adverse events involving medical devices, including surgical robots.

A peer-reviewed study analyzed FDA MAUDE data from 2000 to 2013 and identified 10,624 adverse event reports associated with robotic surgical systems, including 1,391 reports of patient injury and 144 patient deaths. (Source: Alemzadeh et al., PLOS ONE, 2016)
The same study found that the most common device-related issues were system errors and instrument/accessory malfunctions, which accounted for a significant portion of reported events.
Adverse event reporting has continued to grow. Since the Alemzadeh study's data period ended, thousands of additional reports have been filed with the MAUDE database, reflecting both increased device usage and expanded reporting requirements. (Source: FDA MAUDE Database)
Intuitive Surgical's own SEC filings have disclosed thousands of product liability claims and lawsuits filed against the company over the years related to the da Vinci system. (Source: Intuitive Surgical SEC Filings)

It is important to note that MAUDE reports are voluntary for healthcare professionals and may underrepresent the true number of adverse events. Researchers have noted that underreporting is a well-documented limitation of passive surveillance systems.

Is It Medical Malpractice or Product Liability?

One of the most important questions in a surgical robot injury case is whether the harm resulted from surgeon error, a device defect, or some combination of both. The answer determines who can be held liable and what legal theories apply.

Medical Malpractice

A medical malpractice claim may apply when the surgeon, surgical team, or hospital failed to meet the standard of care. In robotic surgery cases, this can include:

Insufficient training or experience on the robotic system
Failure to recognize and respond to intraoperative complications
Improper patient selection for a robotic procedure
Failure to obtain adequate informed consent, including disclosing the risks specific to robotic surgery
Delayed diagnosis of post-operative complications caused by the procedure

Product Liability

A product liability claim targets the device manufacturer when a defect in the surgical robot caused or contributed to the injury. There are three main types of product defects:

Design defects: Flaws inherent in the robot's design that make it unreasonably dangerous for its intended use
Manufacturing defects: Errors during production that cause a specific unit to deviate from its intended design, such as a faulty component or contaminated instrument
Marketing defects (failure to warn): Inadequate instructions, training materials, or warnings about known risks associated with the device

In many surgical robot cases, both the manufacturer and the medical team may share liability. For example, a device malfunction may be compounded by a surgeon's failure to recognize the problem and convert to open surgery in time. An experienced attorney can investigate the facts of your case and identify all potentially responsible parties.

If you believe your surgical complications were not simply an unavoidable risk of surgery, a free case evaluation can help clarify whether you have grounds for a claim.

Types of Compensation Available

Patients who successfully pursue a surgical robot injury claim may be entitled to several categories of compensation, depending on the severity of the injury and the circumstances of the case.

Medical Expenses

This includes the cost of treating the initial injury as well as any subsequent care, such as corrective or revision surgeries, hospitalization, diagnostic imaging, physical therapy, prescription medications, and ongoing medical monitoring. Future anticipated medical costs may also be included.

Lost Wages and Earning Capacity

If your injury prevented you from working during recovery or permanently reduced your ability to earn a living, you may be compensated for both past lost income and diminished future earning capacity.

Pain and Suffering

Compensation for pain and suffering accounts for the physical pain, emotional distress, anxiety, depression, and reduced quality of life caused by the injury. While these damages are non-economic, they often represent a significant portion of the total recovery in surgical injury cases.

Disfigurement and Permanent Disability

Surgical robot malfunctions can result in organ damage, nerve injuries, severe scarring, and permanent functional limitations. Compensation may be available for the lasting impact on your appearance, physical capabilities, independence, and quality of life.

Punitive Damages

If the robot manufacturer knew about defects or safety risks and failed to disclose them to hospitals and patients, or if a hospital continued using equipment with a known history of malfunctions, punitive damages may be awarded to punish the wrongdoer and deter similar conduct.

Wrongful Death

When a surgical robot complication results in the death of a patient, surviving family members may file a wrongful death claim. These claims can provide compensation for funeral and burial expenses, loss of financial support, loss of companionship, and the emotional toll on the family.

Every case is different, and the compensation available depends on the specific facts involved. Speaking with an attorney who handles surgical robot injury cases is the best way to understand what your claim may be worth.

Frequently Asked Questions About Surgical Robot Injuries

Is the da Vinci surgical robot safe?

The da Vinci system has been used in millions of procedures and is FDA-cleared for many types of surgery. However, no medical device is without risk. The FDA's MAUDE database contains thousands of adverse event reports linked to the da Vinci system, including instrument malfunctions, electrical arcing burns, and unintended tissue damage. Whether the device was at fault in your case depends on the specific circumstances of your surgery and the nature of the complication.

Can I sue the hospital or surgeon for a surgical robot injury?

Yes, you may have a medical malpractice claim against the surgeon, hospital, or surgical team if they were negligent in operating the robotic system, failed to obtain proper informed consent, or lacked adequate training on the device. Hospitals may also be liable for failing to maintain or inspect the equipment. An attorney experienced in surgical robot cases can evaluate whether the hospital or surgeon bears responsibility.

What is the difference between product liability and medical malpractice in surgical robot cases?

Product liability holds the device manufacturer responsible when a defect in the robot caused or contributed to your injury. This can include design defects, manufacturing defects, or inadequate warnings. Medical malpractice holds the surgeon or hospital responsible when human error during the procedure caused the harm. In many surgical robot cases, both theories may apply, and an experienced attorney can help determine which parties are liable.

How do I prove a surgical robot caused my injury?

Proving a surgical robot injury claim typically requires expert medical testimony, the operative report, device malfunction logs, and FDA adverse event data. Your attorney may also obtain the robot's usage and maintenance records from the hospital. Expert witnesses can analyze whether the complication was caused by a device defect, surgeon error, or both. Preserving evidence early is critical, so consulting an attorney promptly after discovering your injury is important.

What is the statute of limitations for surgical robot injury claims?

Statutes of limitations vary by state and by the type of claim. Medical malpractice claims typically must be filed within one to three years from the date of injury or the date you discovered (or should have discovered) the injury, with some states allowing as little as one year. Product liability claims may have different deadlines. Because these time limits are strict and vary significantly, it is essential to speak with an attorney as soon as possible to protect your right to file a claim.

What compensation can I recover in a surgical robot injury lawsuit?

Depending on the circumstances, you may be able to recover compensation for medical expenses (including corrective surgeries), lost wages and reduced earning capacity, pain and suffering, emotional distress, and loss of quality of life. In cases involving death, the family may pursue a wrongful death claim. The specific damages available depend on your state's laws and the facts of your case.

What should I do if my robotic surgery went wrong?

If you believe your robotic surgery did not go as planned, seek a second medical opinion immediately and request your complete operative report and medical records. Document your symptoms, complications, and any additional treatments you have needed. Do not delay — statutes of limitations for medical malpractice claims can be as short as one year in some states. An attorney experienced in robotic surgery cases can review your records and determine whether you have a viable claim against the surgeon, the hospital, or the device manufacturer.

The information on this page is for general educational purposes only and does not constitute legal advice. Injured By Robots LLC is not a law firm and does not provide legal services. Statutes of limitations, filing deadlines, and legal procedures vary by state and are subject to change. This content may not reflect the most current laws in your jurisdiction. No attorney-client relationship is formed by reading this content or submitting a case review. For advice about your specific situation, consult a licensed attorney in your state.

Related Resources

Learn more about robotic and automated system injuries and your legal rights:

Warehouse Robot Injuries -- Injuries caused by autonomous systems in fulfillment centers and warehouses.
Self-Driving Car Accidents -- Legal options after an autonomous vehicle accident.
Your Rights After a Robot Injury -- Understanding your legal options after being injured by a robot or automated system.

Not sure whether your situation qualifies for a legal claim? There is no cost and no obligation to find out. Request your free case review today and let an attorney evaluate your options.