Incident 5: Collection of Robotic Surgery Malfunctions

Description: Study on database reports of robotic surgery malfunctions (8,061), including those ending in injury (1,391) and death (144), between 2000 and 2013.


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Alleged: Intuitive Surgical developed an AI system deployed by Hospitals and Doctors, which harmed patients.

Incident Stats

Incident ID
Report Count
Incident Date
Sean McGregor

CSETv0 Taxonomy Classifications

Taxonomy Details

Full Description

Reports of robotic surgeries resulting in injury and death between 2000 and 2013 as found in the Manufacturer and User Facility Device Experience (MAUDE) database, a database of both voluntary and mandatory reports of mishaps. Within the 14 year span there are 8,091 recorded malfunctions resulting in 1,391 injuries and 144 deaths. Injuries range from burns from sparks emitted by the machines (n=193), robotic arms becoming dislodged in the patient (n=100), and instances of the surgeon losing control of the machine or the machine powering down unexpectedly (n=52). About 62% of injuries and deaths reported were due to system/hardware error, while the remainder were attributed to the inherent risk of surgery or human error.

Short Description

Study on database reports of robotic surgery malfunctions (8,061), including those ending in injury (1,391) and death (144), between 2000 and 2013.



Harm Type

Harm to physical health/safety

AI System Description

Robotic surgery tools

Sector of Deployment

Human health and social work activities

Relevant AI functions


AI Techniques

Robotic surgery tools

AI Applications

Robotic Surgery


United States of America

Named Entities

da Vinci Robot, FDA

Beginning Date


Ending Date


Near Miss

Harm caused



Lives Lost


Infrastructure Sectors

Healthcare and public health

Data Inputs

Surgeon's directions, medical procedures

CSETv1 Taxonomy Classifications

Taxonomy Details

Harm Distribution Basis


Sector of Deployment

human health and social work activities · 2015

Importance: Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future.

Objective: To determine the frequency, causes, and patient impact of a…

Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data · 2015

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Robotic Surgery Linked To 144 Deaths Since 2000 · 2015

Robotic surgeons were involved in the deaths of 144 people between 2000 and 2013, according to records kept by the U.S. Food and Drug Administration. And some forms of robotic surgery are much riskier than others: the death rate for head, n… · 2015

MIT Technology Review: According to a recent study, most of the robotic surgical procedures performed over the past 14 years have gone smoothly. However, a significant number have suffered some sort of adverse event, even if it did not resu…

Robotic Surgery Involved in 144 Deaths in 14 Years · 2015

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July 21, 2015, 4:04 PM GMT / Updated July 21, 2015, 7:53 PM GMT By Keith Wagstaff

Robotic surgery is on the ris…

Robotic Surgery Has Been Connected to 144 U.S. Deaths Since 2000 · 2015

All surgery carries risk, and that’s also true when it involves robots. A new study of U.S. Food and Drug Administration data reveals that a variety of malfunctions have been linked to 144 deaths during robotic surgery in the last 14 years.…

Botched Robotic Surgeries Have Been Linked to 144 Patient Deaths · 2015

An independent analysis of reports gathered by the U.S. Food and Drug Administration since 2000 shows that robotic surgery isn’t as safe as some people might assume.

Surgery involving robots, where a surgeon guides the steady and precise mo…

Robotic surgery may be the future, but right now it’s consistently janky · 2015

The Food and Drug Administration keeps meticulous records concerning instances of medical devices, including robots, malfunctioning or acting in ways that they aren’t supposed to.

Those records are stored in the Manufacturer and User Facili… · 2015


The use of robotic systems for some forms of surgery is still a relatively new area, but they have been in use long enough for researchers from MIT, the University of Illinois at Urbana-Champaign, and Rush University Medical Center in…

Robotic surgery linked to 144 deaths in the US · 2015

Image copyright Science Photo Library Image caption Surgical robots allow doctors to improve recovery time and minimise scarring

A study into the safety of surgical robots has linked the machines' use to at least 144 deaths and more than 1,…

Robot surgeons kill 144 patients, hurt 1,391, malfunction 8,061 times · 2015

Surgery on humans using robots has been touted by some as a safer way to get your innards repaired – and now the figures are in for you to judge.

A team of university eggheads have counted up the number of medical cockups in America reporte…

Robotic surgeries: Really safe? · 2015

A series of reports submitted to the U.S. Food and Drug Administration since 2000 were analyzed and it was found that robotic surgeries are not safe after all.

In recent years, the use of surgical robots in the medical community has increas…


A "variant" is an incident that shares the same causative factors, produces similar harms, and involves the same intelligent systems as a known AI incident. Rather than index variants as entirely separate incidents, we list variations of incidents under the first similar incident submitted to the database. Unlike other submission types to the incident database, variants are not required to have reporting in evidence external to the Incident Database. Learn more from the research paper.

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