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Page 12 of 16 Nawrat. Mini-invasive Surg 2020;4:28 I http://dx.doi.org/10.20517/2574-1225.2020.08

The robot has the right to break. It is not allowed to make a move without the consent of the operator.
During power outages and other problems, it must be possible to remove the tools from the patient by
means of a medical team. I myself was a witness to this in the early phase of implementation of the da Vinci
robot: during an on-line operation for its participants at a conference in Leipzig, one of the arms of the da
Vinci robot stopped listening to the surgeon’s hand. Our excellent colleague continued his classic surgery
without squinting. Experience and skills, reason and knowledge always promote happiness.

Excessive optimism related to the shorter path of gaining experience in robotic operations was the reason
for many crisis situations and simple mistakes. The patient’s death during the first mitral valve surgery with
a robot in the UK was resounding. The surgeon lost visibility after damage to the aorta which flooded the
camera. The patient died. “An inquest has heard how Sukumaran Nair lobbied to be allowed to perform a
mitral valve repair using a state-of-the art Da Vinci robot, despite performing slowly during non-robotic
[21]
operations and passing up opportunities to practice on the machine” .
The da Vinci robot is a telemanipulator. The control system allows you to direct the movement of the
tools using the movement of the hand of the surgeon sitting at the console. Sometimes the control signal
transmission system (e.g., cable damage) or movement mechanism (e.g., mechanical damage) fails. Here
is an example of the description of such an event noted by the FDA: “System error codes #20009 and
#21009 appear when the da Vinci safety system determines a differential change in the angular position
of one or more robotic joints on the specified manipulator, as measured by that joint’s primary control
sensor encoder and the secondary sensor potentiometer. The system alarm system generated fault code-
functioned as designed and there was no injury to the pt. Upon determining this condition, the safety
[22]
system put da vinci in a “recoverable safe state” .
The FDA has an online database MAUDE (Manufacturer and User Device Experience) filed by manufacturers,
health care facilities, patients and lawyer, and includes thousands of incidents (ranging from error code
bugs to patient deaths) related to the use of various da Vinci robotic systems. In Homa Alemzadeh and
colleagues “A Retrospective Study of 14 Years of FDA Data” summarized that between 2000 and 2013, a
total of 144 deaths, 1391 patient injuries and 8061 device malfunctions were reported with robotic surgery
(10,624 reports at a time when 1.75 million robotic procedures were performed). 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 1104 (10.4%) of all the events, the procedure
was interrupted to restart the system (3.1%), convert the procedure to non-robotic techniques (7.3%), or to
[23]
reschedule it (2.5%) .
According to the FDA database, in the 5-year period ending on Aug 31, 2017, the agency received 30
reports of incidents in which the patient died in connection with surgery using the da Vinci system. The
system did not necessarily cause those deaths, but they occurred after or during surgery in which surgeons
used the system. During the same time period, the FDA received 282 reports involving patient injury.

Experts say that the main contributing factors to robotic surgery adverse-event reports are: device failure
(30%), device operational/setup (25%), user error (20%), inadequate training (7%), maintenance issue (7%)
[24]
and others (11%) .
That’s all for the manipulator. The equipment or person may fail. But if we were to have an autonomous
robot, who or what will be considered guilty? Who will be responsible for the wrong diagnosis or bad
result from surgery? Engineer, constructor, director (owner) of the hospital, the supervising doctor or