Incident 5: Collection of Robotic Surgery Malfunctions
Entities
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CSETv1 Taxonomy Classifications
Taxonomy DetailsHarm Distribution Basis
none
Sector of Deployment
human health and social work activities
CSETv0 Taxonomy Classifications
Taxonomy DetailsFull 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.
Severity
Severe
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
Action
AI Techniques
Robotic surgery tools
AI Applications
Robotic Surgery
Location
United States of America
Named Entities
da Vinci Robot, FDA
Beginning Date
2000-01-01T00:00:00.000Z
Ending Date
2013-01-01T00:00:00.000Z
Near Miss
Harm caused
Intent
Accident
Lives Lost
Yes
Infrastructure Sectors
Healthcare and public health
Data Inputs
Surgeon's directions, medical procedures
Incident Reports
Reports Timeline
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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…
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Copyrig ht © 2015: Author s. !
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Appendix
Underre porti ng
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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…
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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.…
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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…
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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…
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Close
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…
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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…
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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…
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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,…
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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…
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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…
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