Robotic surgical systems like the da Vinci have transformed modern surgery—but they’ve also created new categories of patient injury. When a surgical robot malfunctions or is operated improperly, patients may suffer burns, organ damage, or worse. With 7+ million procedures performed worldwide and ongoing FDA recalls, understanding your legal options is essential.
The Surgical Robotics Market in 2025#
The global surgical robot market reached $11.48 billion in 2024 and is projected to grow at 12.4% annually through 2030. Intuitive Surgical’s da Vinci system dominates with approximately 70% market share, but new competitors are entering the field.
Market Leaders#
| Company | System | FDA Status | Market Position |
|---|---|---|---|
| Intuitive Surgical | da Vinci (Xi, 5) | Cleared | 70%+ market share, 7M+ procedures |
| Medtronic | Hugo RAS | Cleared Dec 2025 | First major competitor for soft tissue |
| Stryker | Mako | Cleared | Orthopedic leader, 1M+ procedures |
| Johnson & Johnson | OTTAVA | Clinical trials (2025) | Targeting general surgery |
Da Vinci 5: The Latest Generation#
Intuitive Surgical received FDA clearance for the da Vinci 5 in March 2024, featuring:
- New surgeon controllers with force feedback
- Advanced vibration and tremor controls
- 10,000+ components (most complex medical device)
Da Vinci 5 Recall (2025)
New Competitor: Medtronic Hugo#
On December 3, 2025, Medtronic received FDA clearance for the Hugo RAS system—the first major competitor to da Vinci for soft tissue surgery in the U.S. in over two decades.
Hugo cleared indications:
- Prostatectomy
- Nephrectomy
- Cystectomy
The Expand URO clinical trial showed a 98.5% surgical success rate. Medtronic plans to expand into hernia repair and gynecologic procedures.
Liability implications: As Hugo enters the market, patients may face questions about which system caused their injury—the established da Vinci or the newer Hugo. Both manufacturers may be liable depending on the device used.
FDA Adverse Event Data: The Numbers#
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database tracks medical device problems. The data reveals consistent patterns of harm from surgical robots.
Historical Data (2000-2013)#
A comprehensive study analyzing 14 years of FDA data found:
| Category | Number | Percentage |
|---|---|---|
| Total adverse events | 10,624 | 100% |
| Patient deaths | 144 | 1.4% |
| Patient injuries | 1,391 | 13.1% |
| Device malfunctions | 8,061 | 75.9% |
The injury and death rate remained relatively constant at approximately 83.4 incidents per 100,000 procedures.
2008-2018 Decade#
By 2018, adverse events involving the da Vinci system exceeded 20,000 reports, including:
- More than 2,000 reports of severe injuries
- 274 reports of patient deaths
- 186+ recalls related to the device since 2005
Underreporting Warning
Common Surgical Robot Injuries#
Patients injured by surgical robots report a range of complications:
Electrical and Thermal Burns#
The da Vinci system uses electrosurgical instruments that can cause burns if current leaks to unintended areas. Research from the University of Western Ontario tested 37 da Vinci instruments and found all of them had “energy leakage”—some sufficient to cause electrical burns.
How it happens: Cracks or slits in rubber tip covers allow electricity to escape without surgeons’ knowledge, burning internal organs. A surgeon would rarely be aware of arcing during a procedure, and symptoms may take several days to appear.
Organ Perforation and Laceration#
Robotic arms operating inside the body can puncture or tear organs.
2024 Case Example: In February 2024, a wrongful death lawsuit alleged that a da Vinci robot burned and perforated a patient’s small intestine during colon cancer surgery. Sandra Sultzer developed complications and died months later. The lawsuit alleges Intuitive knew about insulation problems but didn’t disclose the risk.
Uncontrolled Movements#
System malfunctions can cause robotic arms to move unpredictably, potentially causing internal damage that may not be immediately apparent.
Extended Surgical Times#
When robots malfunction mid-surgery, the resulting delays can increase infection risk and complicate procedures. Studies show surgical delays averaging nearly 18 minutes in reported incidents, with some lasting an hour.
Conversion to Open Surgery#
Robot failures sometimes require emergency conversion to traditional open surgery, negating the benefits of minimally invasive approaches and increasing patient risk.
Recent Recalls and Safety Issues (2024-2025)#
Da Vinci 5 Recalls#
| Date | Product | Issue | FDA Class |
|---|---|---|---|
| Feb 2025 | Da Vinci 5 Foot Tray | Pedal spring failures causing stuck pedals | Class II |
| 2024 | Da Vinci 5 Endowrist Vessel Sealer Extend | Insufficient sealing potential | Class II |
| March 2024 | Da Vinci 5 | Initial FDA clearance granted | — |
FDA Warnings#
The FDA has warned doctors and patients against using robotically-assisted devices for certain cancer surgeries based on research showing poor outcomes in cancer patients. The 2013 FDA warning letter to Intuitive criticized the company’s safety notification procedures and failure to report malfunctions.
Legal Avenues: Product Liability vs. Medical Malpractice#
When surgical robots injure patients, two primary legal theories apply—and many cases involve both.
Product Liability Claims#
If the robot itself is defective, the manufacturer (Intuitive Surgical, Medtronic, etc.) may be liable.
Design Defects: The robot’s fundamental design is unreasonably dangerous. For example, claims that da Vinci’s electrosurgical instruments are prone to energy leakage that causes burns.
Manufacturing Defects: A specific unit was improperly assembled or contains faulty components.
Failure to Warn: The manufacturer didn’t adequately warn surgeons or patients about known risks.
Elements to prove:
- The product was defective
- The defect existed when it left the manufacturer
- The product was used as intended
- The defect caused the patient’s injury
Medical Malpractice Claims#
If the surgeon or hospital acted negligently, they may be liable even if the robot functioned properly.
Common malpractice claims:
- Inadequate Training: Surgeons performing procedures without sufficient training
- Improper Patient Selection: Using robotic surgery when traditional approaches would be safer
- Negligent Operation: Errors in controlling the robot during surgery
- Failure to Monitor: Not properly maintaining or inspecting equipment
- Failure to Convert: Continuing with robotic surgery when complications indicate switching
Pursuing Both Claims#
Many cases target both the manufacturer and healthcare providers.
Settlement examples:
- $1.5 million (Michigan, 2017): Da Vinci-assisted hysterectomy where surgeon cut patient’s inferior vena cava
- $250,000 + $790,000 (separate settlements): Intuitive settlement plus patient compensation fund
- $67 million fund (2014): Intuitive Surgical set aside to settle approximately 3,000 claims
As of February 2024, Intuitive Surgical disclosed approximately 93 active da Vinci lawsuits in SEC filings.
Building a Strong Case#
If you’ve been injured during robotic surgery, consider these steps:
1. Document Everything#
Request complete copies of your medical records, including:
- Operative reports
- Nursing notes
- Equipment maintenance logs
- Device serial numbers
Note symptoms and complications as they develop.
2. Understand the Timeline#
| Claim Type | Typical Statute of Limitations |
|---|---|
| Medical malpractice | 1-3 years (varies by state) |
| Product liability | 2-4 years (varies by state) |
| Discovery rule | May extend deadline from date injury discovered |
3. Consult Specialized Attorneys#
These cases require expertise in both medical malpractice and product liability law, plus technical understanding of robotic surgical systems.
4. Preserve Evidence#
If possible, ensure the hospital preserves the specific robotic instruments used in your surgery. This evidence can be crucial for proving manufacturing defects.
Questions to Ask After Robotic Surgery Complications#
If you experienced complications after robotic surgery, investigate:
- Was my surgeon adequately trained and credentialed for robotic procedures?
- Were there any equipment malfunctions during my surgery?
- Has this hospital or surgeon had previous robotic surgery complications?
- Were the robotic instruments properly maintained and inspected?
- Did any FDA recalls affect equipment used in my procedure?
- Which specific device and software version was used?
The Future of Surgical Robot Liability#
As surgical robots become more autonomous and AI-assisted, liability questions grow more complex.
Emerging Issues#
Competition: With Medtronic Hugo now cleared and J&J’s OTTAVA in clinical trials, the da Vinci monopoly is ending. More manufacturers mean more potential defendants—and potentially more finger-pointing between companies.
AI Integration: As AI assists with surgical planning and real-time decision-making, determining responsibility when automated systems contribute to harm becomes more difficult.
International Expansion: Medtronic Hugo is already available in 30+ countries and has been used in tens of thousands of procedures. International variations in regulatory standards may complicate litigation.
Frequently Asked Questions#
Related Resources#
On This Site#
- Da Vinci Robotic Surgery Injuries — Comprehensive guide to da Vinci complications and lawsuits
- Medical AI — AI in diagnostic and treatment decisions
- Industrial Automation — Robot safety in manufacturing settings
Partner Sites#
- Surgical Robotics Practice Area — Find law firms specializing in surgical robot injury cases
- Healthcare AI Standards — Professional standards and guidelines for AI in medical settings
Injured During Robotic Surgery?
Surgical robot injuries are complex cases requiring expertise in both product liability and medical malpractice law. With the 2025 da Vinci 5 recall, new competitors entering the market, and over 20,000 adverse events reported to the FDA, injured patients have multiple potential claims. Connect with attorneys who understand robotic surgical systems and can identify all responsible parties.
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