Malfunctions of robotic system in surgery: role and responsibility of surgeon in legal point of view
This literature review examines the impact and legal implications of robotic system malfunctions in surgery based on published data and the FDA MAUDE database. It finds that device malfunctions are relatively rare and highlights that while surgeons generally bear little direct legal responsibility for equipment failures, proper technical training and patient informed consent regarding potential device failure are necessary.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Surgeons, legal medicine specialists, and researchers studying medical device liability and robotic surgery.
What the document contains
The document covers the frequency, types, and literature-reported impacts of robotic surgical device malfunctions, alongside an analysis of the surgeon's legal responsibilities and training needs.
Specific AI governance guidelines, statutory regulations, or binding legal mandates regarding autonomous surgical systems are not provided.
- Robotic system malfunctions in surgery are rare according to literature and database reviews.
- Most robotic procedure failures are traditionally due to surgeon inability or device dysfunction.
- Surgeons generally do not bear direct legal responsibility for equipment failures originating from manufacturing standards.
- Surgical training programs should include technical knowledge of robotic devices and troubleshooting.
- Informed consent should include communicating the possibility of robotic system failure to patients.
· 1 Introduction · 2 Methods · 3 Results · 4 Discussion - 4.1 Robotic malfunctions - 4.2 Legal implications · 5 Limits of the study · 6 Conclusions
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
3/5Clear responsibility for AI outcomes
Nothing In the literature clearly defines surgeons’ legal responsibility in RMs: lesions due to these problems appear not to be the surgeon’s responsibility, but imputable to the instrument and therefore to the manufacturer.
4.2 Legal implications
screening score · 2026-10-24
Fairness
0/5Non-discrimination and equitable treatment
screening score · 2026-10-24
Human Dignity
0/5Respect for the inherent worth of persons
screening score · 2026-10-24
Human Oversight
2/5Humans remain in control of consequential decisions
However, if an RM occurs after the induction the surgeon must be able to deal with the problem, either directly or by calling in device specialists
4.1 Robotic malfunctions
screening score · 2026-10-24
Privacy
0/5Protection of personal data and private life
screening score · 2026-10-24
Transparency
2/5Openness about how AI systems work and are used
Throughout the IC acquisition, in a surgery based on advanced technologies, informing the patient about eventualities such as robot malfunctioning and execution modalities becomes necessary
4.2 Legal implications
screening score · 2026-10-24
Enforcement
0/5Consequences and compliance mechanisms with real force
screening score · 2026-10-24
Impact Assessment
1/5Required assessment of an AI system's risks/impacts before or during use
We reviewed the literature to estimate the impact of this second circumstance in RS and its consequent legal implications.
Abstract
screening score · 2026-10-24