Surgical robot error logs are proprietary and hidden from hospitals

medical-devices+20 views
When a surgical robot like the da Vinci system experiences a fault during an operation -- such as an instrument arm freezing, a sudden instrument swap demand, or a visual display glitch -- the detailed error log is encrypted and accessible only to the manufacturer (Intuitive Surgical). The operating surgeon receives a generic fault code and must file a service request to learn what happened, often waiting days for a response while needing to complete an incident report immediately. Hospitals cannot independently audit robotic failure patterns across their own cases to identify systemic issues. This persists because manufacturers classify error logs as proprietary trade secrets, and the FDA does not require that hospitals or clinicians have real-time access to device diagnostic data during or after procedures.

Evidence

https://jamanetwork.com/journals/jama/fullarticle/2779851

Comments