Homa Alemzadeh, Ravishankar. Iyer, Zbigniew Kalbarczyk, Nancy Leveson, Jai Raman
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
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.