  Understanding the causes and patient impacts of surgical adverse events will
help improve systems and operational practices to avoid incidents in the
future. We analyzed the adverse events data related to robotic systems and
instruments used in minimally invasive surgery, reported to the U.S. 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.
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%). Adoption of advanced techniques in design and operation of robotic
surgical systems may reduce these preventable incidents in the future.
