What’s New with da Vinci?
Intuitive’s latest iteration of its flagship product, the da Vinci Xi,
launched in the United States in April 2014. As mentioned previously, the favorable market response to the new system was
a large driver in the company’s overall revenue increase: 492 da
Vinci systems were sold globally in 2015, 61 more than the year
prior. As a result, da Vinci procedures also experienced a rise: in
fiscal 2015, approximately 652,000 procedures were performed,
about a 14 percent increase from fiscal 2014.
da Vinci Xi continues to build on the core systems features. It
now includes wristed instruments, 3D high-definition visualization, intuitive motion, and an ergonomic design. Specifically, the
newest version contains an overhead instrument arm to facilitate anatomical access from basically any position and a simpler,
more compact endoscope digital architecture with improved vision definition and clarity (which can be attached to any arm).
The arms themselves were designed to be smaller and thinner
with joints that offer a more flexible range of motion, and the
system’s longer instrument shafts offer surgeons greater operative reach. Xi was CE marked in June 2014, cleared in South Korea in October 2014, and cleared in Japan in March 2015. da Vinci
Xi versions of the EndoWrist stapler 45—a wristed, stapling instrument meant for resection, transection, and/or anastomoses
creation in general, gynecologic, and urologic surgery—were
initially shipped in January 2015. The Endo Wrist Stapler was CE
marked to sell in European markets for the Si and Xi surgical
systems in April 2015.
CE mark clearance was also achieved for da Vinci Xi Integrated
Table Motion product in June 2015. This coordinates da Vinci’s robot arms with a version of the Trumpf Medical TruSystem 7000dV
operating room table, enabling patient position shifting in real-time while the arms remain docked. It permits OR teams to optimally position the operating table so gravity exposes anatomy
during multi-quadrant procedures, allows surgeons to interact
with tissues at an ideal working angle, and repositions the table
during procedures to assist the anesthesiologists’ care. It was
introduced in phases to the European market in fourth quarter
2015, and was cleared by the FDA in January 2016.
With Great Innovation Comes Great Litigation
As of Dec. 31, 2015, Intuitive was named as a defendant in
about 92 individual product liability lawsuits, alleging that a va-
riety of personal injuries—and in some cases, death—resulted
from botched da Vinci surgical system procedures. In fact, as
recently as Dec. 21, plaintiffs in a Missouri legal action added
10 additional plaintiffs, seeking damages on behalf of 55 pa-
tients who underwent da Vinci surgeries in 22 different states.
This isn’t exactly news for Intuitive, which has been receiv-
ing a steady stream of lawsuits related to da Vinci procedures
gone awry since the product’s launch. The most recent allega-
tions assert that da Vinci’s defects and/or Intuitive’s failure to
adequately train healthcare professionals performing the sur-
geries resulted in the injuries. Further, the plaintiffs claim that
Intuitive did not disclose and/or misrepresented the benefits
and risks of the device.
Initiated by plaintiffs’ attorneys, da Vinci has also been subject
to well-funded national advertising efforts directed at patients
dissatisfied with their surgery. The company has received a sig-
nificant amount of claims relating to alleged surgical complica-
tions from surgeries using the Monopolar Curved Scissor (MCS)
instruments—the tip cover accessory for these were withdrawn
from the market in 2012, and MCS instruments were the sub-
ject of a recall in 2013. One recent case, which is now before the
Washington State Supreme Court awaiting review, specifically
accused the company of failing to properly train, warn, and in-
struct the operating surgeon.
Product liability litigation is such a concern for Intuitive that
the company often enters into tolling agreements to minimize
the expense and distraction of defending multiple lawsuits. Pre-tax charges of these agreements were $13.8 million, thankfully
significantly down from 2014’s $82.4 million.
Research and Training Initiatives
Toward the end of February 2015, Intuitive began a partnership with the American Hernia Society Quality Collaborative
(AHSQC). Joining six other foundation partners, this initiated a
surgeon-led, online quality initiative to share real-time patient
data regarding abdominal hernias, review peer and institutional
data, and analyze best practices, decision support, and care pathways. “It is critical that we follow and track the results of our
operations to determine the best options that help our patients.
We should all take responsibility for fostering a culture of quality
improvement,” Dr. Benjamin K. Poulose, M.P.H., AHSQC director of quality and outcomes, said in a company press release. The
study sought to address and improve upon health outcomes for
hernia patients as well as optimize costs for surgical hernia repair
by assessing factors responsible for hernia occurrence, quality of
life following hernia repair, reducing surgical-site complications,
evaluating advantages of minimally invasive repair, and minimizing perioperative pain.
The company announced a different type of quality initiative in August 2015, when simulator grants were awarded by
Intuitive to five top U.S. medical centers to advance training in
robotic-assisted minimally invasive surgery. The goal was to interpret how surgical skills learned in a virtual-reality environment translate to improved inter-operative skills, simultaneously identifying training needs and determining the research
required to address those needs.
“As the da Vinci Surgical Systems emerge on the forefront of
minimally invasive surgery, validation of safe training curricula
for residents, fellows, and practicing surgeons will have to be
sought with careful, scientific rigor,” Shawn Tsuda, M.D., FACS,
associate professor of surgery at the University of Nevada School
of Medicine, said in a press release.“This grant enables forward-looking programs to develop best-practices for integrating robotics into surgical training.”