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Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data (arxiv.org)

Richard M Stein <rmstein@ieee.org>
Tue, 19 Jun 2018 13:53:56 -0700
Homa Alemzadeh, Ravishankar. Iyer, Zbigniew Kalbarczyk, Nancy Leveson, Jai Raman
http://arxiv.org/pdf/1507.03518.pdf

An acquaintance expressed enthusiasm for their forthcoming robotic surgical
procedure. The well-respected Southern California National Cancer Institute
at the City of Hope—a hospital and medical- industrial complex—effused
the benefits of the "world's best robotic surgeon."

Being cautious about a hard-sell, I sent a link to this report with a few
choice questions to inquire about before signing the consent form.  Wonder
what this analysis would show for the past 4+ years of MAUDE data? Similar
trend, better, or worse?

>From the summary page:

  Methods: Weanalyzed the adverse events data related to robotic systems and
  instruments used in minimally invasive surgery, reported to the U.S. Food
  and Drug Administration (FDA) MAUDE database from January 2000 to December
  2013. We determined the number of events reported per procedure and per
  surgical specialty, the most common types of device malfunctions and their
  impact on patients, and the causes for catastrophic events such as major
  complications, patient injuries, and deaths.

  Results: During the study period, 144 deaths (1.4% of the 10,624 reports),
  1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were
  reported. The numbers of injury and death events per procedure have stayed
  relatively constant since 2007 (mean = 83.4, 95% CI, 74.2 [?]  92.7).
  Surgical specialties, for which robots are extensively used, such as
  gynecology and urology, had lower number of injuries, deaths, and
  conversions per procedure than more complex surgeries, such as
  cardiothoracic and head and neck (106.3 vs. 232.9, Risk Ratio = 2.2, 95%
  CI, 1.9-2.6). Device and instrument malfunctions, such as falling of
  burnt/broken pieces of instruments into the patient (14.7%), electrical
  arcing of instruments (10.5%), unintended operation of instruments (8.6%),
  system errors (5%), and video/imaging problems (2.6%), constituted a major
  part of the reports. Device malfunctions impacted patients in terms of
  injuries or procedure interruptions. In 1,104 (10.4%) of the events, the
  procedure was interrupted to restart the system (3.1%), to convert the
  procedure to non-robotic techniques (7.3%), or to reschedule it to a later
  time (2.5%).

  Conclusions: Despite widespread adoption of robotic systems for minimally
  invasive surgery, a non-negligible number of technical difficulties and
  complications are still being experienced during procedures.  Adoption of
  advanced techniques in design and operation of robotic surgical systems
  may reduce these preventable incidents in the future.



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