Medical liability in paediatric robotic surgery – a current concept and a literature review
This article examines the complex medico-legal challenges and liability frameworks associated with pediatric robotic-assisted surgery, analyzing a ten-year institutional experience alongside a narrative literature review. The authors highlight that robotic surgery shifts liability from an exclusively operator-fault model to a shared network involving the surgeon, healthcare institution, and device manufacturer. The paper discusses technical incidents encountered during procedures, the regulatory void surrounding algorithmic and product liability, and the necessity of establishing multi-stakeholder accountability frameworks.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Surgeons, healthcare administrators, legal scholars, and medical device manufacturers seeking to understand liability frameworks in robotic-assisted surgery.
What the document contains
The document addresses medical liability models, technical incidents in pediatric robotic surgery, institutional responsibilities in shared operating environments, and emerging algorithm-related legal considerations.
Specific enforceable statutory regulations or binding administrative codes governing artificial intelligence deployment in pediatric surgery.
- Robotic-assisted surgery shifts the focus from an exclusively fault-based liability of the surgeon to a network-based system involving multiple stakeholders.
- Technical platform-related issues such as joystick latency and pedal malfunctions carry a high potential for severe complications even if they do not cause immediate injury.
- Healthcare institutions incur organizational and institutional liability regarding equipment selection, maintenance, and the safety of shared operating suites.
- Device manufacturers bear strict liability for latent technical, design, or software defects.
- Informed consent in robotic surgery must explicitly detail technical risks, latency, potential mechanical failures, and conversion possibilities.
· Introduction · Materials and methods · Results · Discussion
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
5/5Clear responsibility for AI outcomes
Robotic surgery shifts the focus from an exclusively fault-based liability of the surgeon to a network-based system involving multiple stakeholders: the surgeon, the healthcare institution, and the manufacturer.
Abstract
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
4/5Humans remain in control of consequential decisions
Physicians cannot legally delegate their professional liability to an automated system. Surgeons remain fully responsible for understanding the technological limitations of the platform and must retain the competence to intervene promptly and transition to open or laparoscopic surgery in the event of a system malfunction.
Discussion
screening score · 2026-10-24
Privacy
0/5Protection of personal data and private life
screening score · 2026-10-24
Transparency
3/5Openness about how AI systems work and are used
Parents or legal guardians must be explicitly and comprehensively informed prior to surgery regarding the specific use of robotic technology. This disclosure must go beyond standard surgical risks to detail the unique technical risks associated with robotic systems
Discussion
screening score · 2026-10-24
Enforcement
4/5Consequences and compliance mechanisms with real force
Under current European Union and national legal frameworks, three principal figures can be identified: The Manufacturer: Liable under strict product liability doctrines if a design, manufacturing, or software defect existed at the time the robotic platform was placed on the market.
Discussion
screening score · 2026-10-24
Impact Assessment
4/5Required assessment of an AI system's risks/impacts before or during use
Both stakeholders are legally mandated to implement proactive risk management measures. In the event of litigation, regulatory and judicial authorities will evaluate whether each party fulfilled their respective statutory obligations.
Discussion
screening score · 2026-10-24