Surgical Robotics Standard of Care: da Vinci, Mako, and Robotic Surgery Liability

The Robotic Surgery Revolution

#

Surgical robotics has transformed operating rooms worldwide. The da Vinci Surgical System alone has been used in over 12 million procedures. Orthopedic robots like Mako assist in joint replacements with sub-millimeter precision. Yet with this technological revolution comes a complex liability landscape: who is responsible when a $2 million robot malfunctions, when a surgeon lacks adequate training, or when a hospital fails to maintain the equipment?

This guide examines the standard of care for robotic surgery, the unique liability questions these systems create, and how courts are allocating responsibility among surgeons, hospitals, and manufacturers.

Major Surgical Robotics Systems

#

da Vinci Surgical System (Intuitive Surgical)

#

The dominant player in soft tissue robotic surgery:

Market Position:

• Over 8,600 systems installed worldwide
• Used in 12+ million procedures
• Procedures include prostatectomy, hysterectomy, cardiac surgery, general surgery

System Components:

• Surgeon console (3D visualization, hand controls)
• Patient-side cart (robotic arms, instruments)
• Vision cart (image processing)

Common Procedures:

• Prostatectomy (most common)
• Hysterectomy
• Colorectal surgery
• Cardiac valve repair
• Bariatric surgery

Mako System (Stryker)

#

Leading orthopedic robotic platform:

Applications:

• Total knee arthroplasty
• Partial knee replacement
• Total hip arthroplasty

Technology:

• CT-based 3D bone modeling
• Haptic feedback prevents cutting outside planned boundaries
• Real-time adjustment during surgery

Other Surgical Robotics

#

Mazor X (Medtronic):

• Spine surgery guidance
• Pedicle screw placement

Rosa Knee/Hip (Zimmer Biomet):

• Joint replacement assistance
• Real-time ligament balancing

Hugo RAS (Medtronic):

• General surgery platform
• Modular, portable design

FDA Adverse Event Data

#

MAUDE Database Analysis

#

A comprehensive study of 14 years of FDA MAUDE data revealed significant adverse events:

Event Rates:

• Mean injury/death rate: 83.4 per 100,000 procedures
• Rate relatively constant over study period
• Complex surgeries (cardiothoracic, head/neck) had 2.2x higher rates than routine procedures

Common Device Malfunctions

#

Electrical Arcing: A Major Concern

#

Electrical arcing, when sparks from surgical instruments land in patient tissue, is a leading cause of serious injury:

• Insulation failure causes arcing when protective covers crack or damage
• Surgeons often unaware of arcing during procedure
• Symptoms may not appear for days post-surgery
• Burns to internal organs can be catastrophic

Liability Framework

#

Multi-Party Liability Structure

#

Surgical robotics injuries typically involve multiple potential defendants:

Surgeon:

• Standard medical malpractice claims
• Allegations of inadequate training
• Failure to recognize complications
• Improper patient selection

Hospital/Surgical Facility:

• Negligent credentialing of surgeons
• Failure to properly maintain equipment
• Inadequate training programs
• Insufficient staffing for robotic procedures

Manufacturer (Intuitive Surgical, Stryker, etc.):

• Product liability for design defects
• Manufacturing defects (faulty components)
• Failure to warn of known risks
• Inadequate training materials

The Training Problem

#

A critical liability issue: most surgeons completed training before robotic surgery existed.

No Universal Certification:

• No standardized credentialing system for robotic surgery
• Training requirements vary by hospital
• Manufacturer training programs differ in rigor
• “Proctoring” requirements inconsistently enforced

Liability Implications:

• Hospitals may be negligent for credentialing untrained surgeons
• Surgeons may be liable for operating beyond competence
• Manufacturers may be liable for inadequate training support

The “Black Box” Surgical Recorder

#

Many modern surgical robots record procedure data:

What’s Recorded:

• Instrument movements
• Force data
• Video of surgical field
• System performance metrics

Legal Implications:

• Evidence preservation becomes critical
• Data may prove or disprove negligence
• Spoliation concerns if data deleted
• Manufacturer access to data raises discovery issues

Notable Cases and Settlements

#

Intuitive Surgical Settlement

#

Intuitive Surgical reserved $67 million to settle approximately 3,000 claims:

Common Allegations:

• Electrical arcing causing internal burns
• Instrument failures during procedures
• Inadequate training and warnings
• Marketing claims exceeding evidence

Settlement Rationale: Company determined settling was more cost-effective than litigating thousands of individual claims.

Recent Verdicts

#

Typical Claim Patterns

#

Product Liability Against Intuitive:

• Device malfunctioned causing injury
• Manufacturer failed to warn of known risks
• Training materials were inadequate

Malpractice Against Surgeon:

• Surgeon wasn’t adequately trained
• Failed to recognize complication
• Improper patient selection for robotic approach

Negligence Against Hospital:

• Credentialed surgeon without proper verification
• Failed to maintain equipment properly
• Inadequate support staff during procedure

Standard of Care for Robotic Surgery

#

Surgeon Obligations

#

Pre-Operative:

• Verify appropriate training and credentialing
• Assess patient suitability for robotic approach
• Informed consent including robotic-specific risks
• Equipment inspection and system check

Intra-Operative:

• Maintain situational awareness (robot is tool, not substitute for judgment)
• Recognize when to convert to open surgery
• Monitor for system malfunctions
• Document any equipment issues

Post-Operative:

• Monitor for delayed complications (arcing burns may present days later)
• Recognize atypical post-operative course
• Report adverse events to hospital and FDA MAUDE

Hospital/Facility Obligations

#

Credentialing:

• Verify surgeon training and competence
• Establish minimum case volume requirements
• Require proctoring for new surgeons
• Ongoing competency assessment

Equipment:

• Regular maintenance per manufacturer specifications
• Proper cleaning and sterilization
• Staff training on equipment handling
• Documentation of all maintenance

Staffing:

• Trained surgical team for robotic procedures
• Technical support during procedures
• Adequate OR time for robotic cases (typically longer)

Manufacturer Obligations

#

Training:

• Adequate training programs for surgeons
• Clear competency standards
• Ongoing education as technology evolves

Warnings:

• Clear disclosure of known risks
• Updates when new risks identified
• Communication of adverse event patterns

Design and Manufacturing:

• Quality control for components
• Monitoring for design issues
• Prompt response to safety signals

FDA and Regulatory Considerations

#

FDA Safety Communication

#

The FDA has issued specific guidance on robotic surgery:

Key Points:

• No robotic system specifically approved for cancer prevention/treatment
• Robotic surgery not appropriate for all situations
• Adverse events should be reported to MAUDE
• Patient selection remains critical

Reporting Requirements

#

Mandatory Reporters:

• Manufacturers must report device-related deaths within 30 days
• Hospitals must report device-related deaths
• Quarterly malfunction reports required

Voluntary Reporting:

• Healthcare professionals encouraged to report
• Patients can report through MedWatch
• Early reporting helps identify patterns

MAUDE Database Limitations

#

While MAUDE provides valuable data, limitations exist:

• Underreporting is common
• Causation not verified
• Duplicate reports possible
• Not all malfunctions result in reports

Building a Robotic Surgery Case

#

Key Evidence

#

Device Data:

• Surgical robot logs and recordings
• Maintenance records
• Prior malfunction reports
• Manufacturer communications

Training Documentation:

• Surgeon’s training certificates
• Hospital credentialing files
• Proctoring records
• Continuing education

Medical Records:

• Pre-operative planning
• Intra-operative notes
• Conversion decisions
• Post-operative course

Expert Requirements

#

Robotic surgery cases typically require:

• Surgical expert, Same specialty, robotic experience
• Biomedical engineer, Device design and malfunction analysis
• Human factors expert, Training adequacy, ergonomics
• Hospital administration expert, Credentialing standards

Discovery Challenges

#

Manufacturer Data:

• Trade secret claims for algorithms
• Protective orders for design documents
• Access to other adverse event reports

Hospital Records:

• Peer review privilege claims
• Credentialing committee records
• Quality assurance documents

Risk Mitigation

#

For Surgeons

#

1. Obtain proper training, Manufacturer programs plus hands-on proctoring
2. Document competency, Track case volumes and outcomes
3. Patient selection, Not every patient is a robotic candidate
4. Know when to convert, Open surgery may be safer
5. Report adverse events, Both to hospital and FDA

For Hospitals

#

1. Rigorous credentialing, Verify training before granting privileges
2. Minimum volume requirements, Consider competency thresholds
3. Equipment maintenance, Follow manufacturer protocols exactly
4. Staff training, Entire OR team needs robotic competency
5. Adverse event tracking, Internal quality monitoring

For Patients

#

1. Ask about surgeon experience, How many robotic cases? Outcomes?
2. Understand alternatives, Is robotic approach necessary?
3. Know the risks, Robotic-specific complications
4. Post-operative vigilance, Report unusual symptoms promptly

Frequently Asked Questions

#

Related Resources

#

Medical Device Liability

#

• AI Medical Device Adverse Events, FDA MAUDE analysis
• AI Product Liability, Device liability framework
• Radiology AI Standard of Care, Diagnostic AI liability

Healthcare AI

#

• Healthcare AI Standard of Care, Overview of medical AI standards
• AI Misdiagnosis Case Tracker, Diagnostic failure documentation

Litigation Resources

#

• AI Litigation Landscape 2025, Overview of AI lawsuits