  Robotic telesurgical systems are one of the most complex medical
cyber-physical systems on the market, and have been used in over 1.75 million
procedures during the last decade. Despite significant improvements in design
of robotic surgical systems through the years, there have been ongoing
occurrences of safety incidents during procedures that negatively impact
patients. This paper presents an approach for systems-theoretic safety
assessment of robotic telesurgical systems using software-implemented
fault-injection. We used a systemstheoretic hazard analysis technique (STPA) to
identify the potential safety hazard scenarios and their contributing causes in
RAVEN II robot, an open-source robotic surgical platform. We integrated the
robot control software with a softwareimplemented fault-injection engine which
measures the resilience of the system to the identified safety hazard scenarios
by automatically inserting faults into different parts of the robot control
software. Representative hazard scenarios from real robotic surgery incidents
reported to the U.S. Food and Drug Administration (FDA) MAUDE database were
used to demonstrate the feasibility of the proposed approach for safety-based
design of robotic telesurgical systems.
