Occurred: July 2015
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Surgical robots were responsible for at least 144 deaths and over 1,000 injuries in the US between January 2000 and December 2013, according to researchers, rasiging concerns about the safety and reliability of robotic surgery.
Analysing data submitted by hospitals, patients, device manufacturers and others to the US Food and Drug Administration (US FDA), US researchers unearthed incidents involving electrical sparks causing tissue burns and system errors making surgery take longer than planned.
Some 1,166 cases of broken/burned parts falling into patients' bodies contributed to 119 injuries and one death.
The study notes that the figures represent a small proportion of the total number of robotic procedures, and that the true number could be significantly higher.
Some were sceptical about the study's methodology and findings. The study should be 'treated with caution', according to the UK Royal College of Surgeons. 'The authors note 'little or no information was provided in the adverse incident reports' about the cause of the majority of deaths, meaning they could be related to risks or complications inherent during surgery,' it said.
The researchers did not compare accident rates with similar operations in which robots were not used. The study was not peer reviewed.
Multiple
Operator:
Developer:
Country: USA
Sector: Health
Purpose: Conduct surgical operations
Technology: Robotics
Issue: Accuracy/reliability; Safety
Alemzadeh H., et al (2015). Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data (pdf)
Royal College of Surgeons of England (2015). RCS response to US study on robotic surgery systems
Cormi C. et al (2022). Understanding the surgeon’s behaviour during robot-assisted surgery: protocol for the qualitative Behav’Robot study
John Hopkins Medicine (2013). Robotic surgery complications underreported
Page info
Type: Issue
Published: August 2023