Da Vinci Surgery System- First One Of Its Kind To Get FDA’s Approval

The science has seen many changes decade after decade and most of them are for the betterment. Due to these changes or, we can say discoveries, not only science but people also have been benefited a lot. The confidence & faith by which surgical procedures are performed in the 20th century was not the same if we talk about the 17th or 18th century. It has only happened with continuous research & developments in the field of science, healthcare, and technology.

Practicing surgery started way back in 3000 BC when a small hole was cut in the head. But the purpose of this trephining is still unknown. These kinds of practices were continued through the middle ages and trephining became a method of treatment of migraines. During ancient times, dental surgeries were the most common in South America for filling precious stones in cavities. It was said to be for rituals or religious purposes rather than medical ones. So, the evidence of performing surgical procedures is from the ancient period only and it has paid off to what surgeons practice now.

How surgical practices were changed?

Back in the ancient era, when no anesthetics & antiseptics were there and the human anatomy was only understood by dissection of animals, performing surgery was really dangerous. In the 16th century, Andreas Vesalius who is known as founding fathers of modern surgery completely changed the way how human anatomy was known to people. He was the first person who encouraged and gave the idea of human dissection for education purposes to surgeons & physicians. Andreas was also the professor in Padua and he also corrected anatomy ideas of Greek and some of the misconceptions of Romans.

“De Humani Corporis Fabrica Libri Septem”, a book written by Andreas Vesalius became the basis of human anatomical study. That’s where surgery had a new birth and saw something really positive coming out for it. In the 16th century only, Ambrose Paré, a French army surgeon inspired for the development of surgery. Since then, there is no looking back. In the late 1800s, surgeons began to use anesthesia and the fear of surgery from the patient’s mind was just started fading off. After that every decade saw something new, happening, and helpful in the surgical field that not only made surgeons confident but patients also started believing in them.

Technology and surgery

Da Vinci Surgery System- First One Of Its Kind To Get FDA's Approval 1

Continuous researches and advancements paved the way for the use of machines for performing surgical procedures. The initial thought of using machines for patient care was a bit surprising but not vague. What we see in hospitals, nursing homes, and pathological laboratories now clearly justifies our last sentence. Most of the tests and other procedures are performed with the help of machines only and we do rely on them.

As for performing surgeries, a surgeon needs to have the basics clear with a good experience. A surgeon can use technologically advanced tools & equipment for easing the process and making surgical practice precise. But, what if we talk about performing surgeries by completely using machines with minimal human assistance?  Yes, you might know that it is possible and several studies & experiments have also been carried out successfully. But, do you know about the first robotic surgery system for general laparoscopic surgery which got the FDA’s approval? It is the ‘Da Vinci Surgery System’. Let us see it in detail.

Da Vinci Surgery System

In 1985, for the first time, a robotic arm was used for performing a delicate neurosurgical biopsy. That arm was named PUMA 560 and the surgery it assisted in was non-laparoscopic. Then the same year first robotic system assisted laparoscopic surgery cholecystectomy (removal of gall bladder) was performed, thanks to PUMA 560 assisted neurosurgical biopsy earlier.

Later in the year 2000, the Da Vinci Surgical System grabbed all the attention when it became the first FDA approved robotic system for performing general laparoscopic surgeries. Why it was the first one to get FDA approval is because, before Da Vinci System, none of such systems had surgical instruments & cameras on a single machine. This was the first of its kind to have encompassed all of these plus the approval. Before this system, AESOP got FDA approval in the year 1990 for performing the endoscopic surgical procedure.

The specialty about Da Vinci

First, let us see the reason behind the name of this robotic surgery system. It is said that the study of human anatomy by Leonardo Da Vinci has led to the development of the first-ever known robot’s design in history. Due to which this system was named as ‘Da Vinci Surgery System’.

This system is quite different from other robotic surgery systems as it is equipped with high-quality cameras, whereas other models that were used before this system required the use of endoscopes. It is greatly admired for providing a clear high-resolution three-dimensional view of the operative area. This gives a better understanding of the operative area to the surgeons.

Da Vinci is also known for having a small-sized surgical arm with a diameter of about 1 centimeter which is much less as compared to other systems. This somehow has greatly reduced the chances of infections as there will be minimal contact between the exposed tissue and the surgical device. The reduced arm size has also helped in increasing the accuracy while performing surgeries with the small operative area.

This whole system is controlled through a console by a surgeon. The development of a robotic surgery system has opened new doors for the future in the field of medicine. It has improved the way by which surgeries are performed and assists in delivering better surgical precision. Da Vinci also gives several other benefits that are listed below:

  • It assures minimally invasive surgical procedures hence the blood loss will also be reduced.
  • Surgeries performed by this system have also seen shorter recovery periods for patients.
  • A shorter hospital stay of patients is also seen who were treated with this robotic surgery system.
  • It ensures precise surgery with less pain afterward.
  • Tiny incisions made by the surgical arm of robots also significantly reduce the risk of infection plus less scarring will be there.

The success story

Made by the American Company Intuitive Surgical, as of now there are more than 4000 of Da Vinci Surgery Systems have been installed worldwide where more than 50% are in the United States itself. Besides, around 2 lakhs of surgeries have been performed by those systems. The surgical procedures that this system can perform are not confined. It is capable of performing a wide range of surgeries including urological, cardiac, gynecologic, prostatectomies, general, and pediatrics. According to the studies, the most number of prostate cancer surgeries performed in the US is done with the help of Da Vinci. The numbers will rise and will also benefit patients across the globe.

The parts

Designed with utmost precision, Da Vinci has made it simpler for the surgeons to perform surgeries with much better control. Both patients and surgeons rely on this great technology. It has three key parts that help in delivering the best performance every time.

Robotic Arms– Da Vinci Surgery System comprises four interactive robotic arms holding a camera and required surgical tools. All of these are collectively known as the patient cart which is positioned alongside the patient’s bed. The configuration of the patient cart can vary according to the model of the surgical system.

Console– Just like a video game, Da Vinci’s console allows the surgeon to move surgical tools precisely with the controls provided on the console. It also comprises a screen to provide a clear 3-D view of the operating site.

Vision Cart– It is a separate system having a screen that delivers a three-dimensional view of the surgical area during operation. The configurations depend upon the model chosen.

These are the three parts of the Da Vinci Surgical System that work in coordination with each other. Apart from these, Da Vinci also has instruments with EndoWrist Technology. This technology gives maximum responsiveness and assists in precise surgical movements. Even with delicate motions, EndoWrist instruments are the best. Some of these instruments include clip appliers, needle drivers, suction & irrigation, and monopolar & bipolar instruments. They can be easily controlled by the surgeon’s console provided with the Da Vinci robotic surgical system.

EndoWrist instruments are inserted into the tiny incisions made by the surgeon along with a high-definition camera. They provide better access to hard-to-reach areas with improved dexterity. With the help of this system, a surgeon can control & maneuver each aspect of the surgery while delivering better outcomes.

Commercially available models of Da Vinci

There are four known models of this robotic surgery system including the Da Vinci SI Surgical System, the Da Vinci X Surgical System, The Da Vinci XI Surgical System, and The Da Vinci SP1 Surgical System.

Out of four, The Da Vinci XI Surgical System is the most advanced version of the robotic surgery system until now. The SP version has only been approved for single-port urological and lateral oropharyngectomy procedures in the US including tongue base resection.

Concerns pertaining to Da Vinci

The first and major concern showed by many regarding this exceptional surgery system is its initial & maintenance cost. It costs around the US $2 million, plus has a maintenance cost of hundreds of thousand dollars annually. Another problem stated by the users is that this system is hard to learn. Some cases have also been reported regarding the death of patients during surgeries performed by the Da Vinci Surgical System. FDA is also investigating such cases and has warned Intuitive in July 2014 to correct alleged violations. If failed to do so, the company will be fined and might result in the seizure of equipment.

FDA also issued a warning letter to the company (intuitive) to take appropriate actions against violations. The authority also conducted an inspection and found that some of the parts used in Da Vinci were misbranded as the company failed to provide any documents or information regarding them.

Some also see the risk of device malfunction during surgeries and that could be life-threatening or might pose a serious condition. Besides, there are also chances of longer operation times and exposure to anesthesia. Despite these risks or concerns, the popularity of robotic surgical procedures is increasing. Plus, research & development is still under process to make things better & much more reliable.

The future of robotic surgeries

With the development and success of the Da Vinci system, the future of surgical procedures involving AI or robotic systems is very promising. Much more advanced technologies are under research and will soon become available for use. Robotic-assisted surgeries will not only be helpful for surgeons or physicians but also gain the patient’s trust. As discussed above, they will also help in quick and better recovery while leading to less post-surgical pain. One point of concern could be the higher cost of surgical procedures. A surgery that includes a robotic system can cost around $3000 to $6000 depending upon the type of surgery and system used. Those who can afford, not a problem but those can’t still have to rely on traditional procedures.

Coming technologies also promise to treat such medical conditions by surgeries that no one would have thought a decade or two ago. The demand for robotic surgery has also increased owing to its accuracy, small scars, less pain, and faster recovery. Patients have already gained faith in these surgical systems and that is going to increase in the future for sure. Da Vinci is just a start; you could see or hear about many more such systems soon.

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