A study analyzing FDA reports from 2000-2013 found that robotic surgical systems were linked to 144 deaths, 1,391 injuries, and 8,061 device malfunctions across over 1.7 million procedures.
Researchers from MIT, University of Illinois at Urbana-Champaign, and Rush University Medical Center analyzed adverse events data from the FDA MAUDE database related to robotic surgical systems used in minimally invasive surgery from January 2000 to December 2013. The study examined over 10,000 incident reports covering more than 1.7 million robotic procedures performed in the US during this period. The analysis revealed 144 deaths (1.4% of reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%). Common malfunctions included broken instrument pieces falling into patients (14.7%), electrical arcing causing burns (10.5%), unintended instrument operation (8.6%), system errors (5%), and video/imaging problems (2.6%). Equipment sparking burned 193 patients, broken pieces fell into 100 patients killing one, and uncontrolled robot movement injured 52 and killed 2. Complex surgeries like cardiothoracic and head/neck procedures had higher complication rates than gynecology and urology procedures. In 1,104 cases (10.4%), procedures were interrupted requiring system restarts, conversion to non-robotic techniques, or rescheduling.
Domain classification, causal taxonomy, severity scores, and national security assessments were LLM-classified and may contain errors.
AI systems that fail to perform reliably or effectively under varying conditions, exposing them to errors and failures that can have significant consequences, especially in critical applications or areas that require moral reasoning.
AI system
Due to a decision or action made by an AI system
Unintentional
Due to an unexpected outcome from pursuing a goal
Post-deployment
Occurring after the AI model has been trained and deployed