DaVinci Surgical System Poses Unusual Patient Risks
for Gynecological Surgeries
The daVinci surgical system has been in the forefront of the
national news lately. Manufactured by Intuitive Surgical, the daVinci is a
complex robotic system which is
represented as being a way in which various surgeries can be
performed in a minimally invasive manner. The company represents that because
the surgeries are
“minimally invasive”, there is less scarring, less blood
loss, and less surgical recovery time for the patient.
To use the system, the surgeon controls the giant robot from
a console. Through small incisions, the tips of the robotic arms are maneuvered
from the console to perform
surgery. The device is most often used in hysterectomies and
other gynecological procedures, but it can be used for other surgeries,
including prostate surgery.
Use of the system is NOT without risk, however. The
FDA’s MAUDE system lists approximately 20,000 adverse events involving the
daVinci over the last decade. The list contains
catastrophic injuries and 274 deaths. In fact, there have
been reported injuries to the ureter, colon, and other tissue and body organs.
There have been reported injuries to
arterial vessels, causing extensive blood loss.
According to a recent report by NBC News, the daVinci has
also had 175 recalls. While some of the recalls were initiated for minor
revisions and changes, some were also
required to prevent additional patient injury. Perhaps most
unexpected, there have been thermal, or burn injuries reported by doctors and
patients. In a 2013 Warning Letter
issued to the manufacturer, the FDA noted problems caused by
electrical arcing. Specifically, it has been reported that electricity
arced from the tip of the robotic arm to the
patient’s flesh, causing the patient to suffer burn/ thermal
injuries. Certainly, most patients who agree to undergo “minimally invasive”
surgery do not expect electrical burn injuries
to tissue or body organs.
While some of the problems with the daVinci are related to
the dangers of the device itself, other problems are attributable to lack of surgeon
training on the device. It is reported
that a surgeon’s inadequate training is a leading cause for
patient injuries. It might surprise patients to know that there are no training
requirements imposed on a surgeon before a surgeon
can use the device. While the manufacturer offers training,
it does not require training before the device is sold. Further, the FDA
has stated that it has no authority
to oversee a surgeon’s training or to impose training
requirements on a surgeon before the device is used on patients.
Thus, a patient given the option of surgery with the daVinci
system is faced with a daunting choice: either opt for an open procedure with
all of the usual risks and down-time of the procedure,
or agree to the robotic technique and trust that the
patient’s surgeon has the capability to control the robot without incurring
injury.