Da Vinci Surgical System
The Da Vinci is a robotic surgery system. Intuitive Surgical developed the Da Vinci, named after the famous scientist Leonardo da Vinci, in order to allow for complex surgery with a less invasive approach. It was granted approval by the FDA in 2000.
The Da Vinci System is most commonly used for hysterectomies and prostate removals, although it can be used for a wide variety of surgeries.
How It Works
When a surgery is performed, the surgeon operates the Da Vinci from a control center in the room. The Da Vinci is most often used to perform prostatectomies, cardiac valve repair and gynecologic surgeries.
The surgeon and the control center are almost always in the same room as the patient. In addition to the control console, to the side of the patient are four robotic arms, controlled by the doctor from the control panel. Three of these arms are used to hold tools and are also able to function as surgery staples, such as scalpels or scissors.
Rather than face the patient, the surgeon looks at a computer image to see the anatomy that he is performing the surgery on.
The Da Vinci’s implements mimic the operation of the human hand; however, the Da Vinci is supposed to lessen risks posed by traditional surgery, such as mistakes that result from a surgeon’s hand tremors.
With the Da Vinci, Surgeons are given increased dexterity and therefore they can perform minimally invasive procedures that involve complex dissection or reconstruction.
Critics of the Da Vinci System say that it is too difficult for doctors to learn and that there is no evidence that it is any more effective than traditional surgery.
Indeed, a study by the Journal of the American Medical Association showed that side effects and blood loss in robotically performed procedures were no less than in traditional surgery.
In addition, the system uses exclusive software that cannot be changed by the physicians that use it, which means that there is a very limited ability to tweak the Da Vinci for problems. Furthermore, its high cost means that many hospitals cannot afford to purchase it.
Another criticism of the system is that it obtained FDA approval by making claims that its product was similar to already-approved products, and that this helped to fast-track approval. Related criticism is that the makers of the Da Vinci System provide inadequate training to those who are going to operate it.
Lawsuit Filed in Kentucky
A Kentucky man has filed a lawsuit over serious injuries he sustained while receiving a prostatectomy performed by the Da Vinci System.
Russell W. Fryman says that the injuries he suffered during the surgery are the result of flaws in the system and that Intuitive Surgical did not provide he or the doctors with adequate warning about potential complications.
Fryman went in for surgery at Baptist Health Lexington in Lexington, Kentucky, on March 18, 2014.
Due to the Da Vinci’s technical malfunctions, such as the ability to cause burns, the lawsuit claims, Fryman “sustained and will continue to suffer from physical and emotional injuries, including rectal injury, fistulas, infections, and blood clots, causing serious permanent physical and mental pain and suffering; the need for multiple surgeries and other procedures and treatment; performance of an ileostomy; loss of enjoyment of life; medical, hospital, surgical, and related expenses; lost wages; and impairment of the ability to work and earn money.”
The lawsuit claims that Fryman was convinced to receive surgery using the Da Vinci System because of claims that it was faster, safer and caused less pain.