The da Vinci surgical system was approved for use by the FDA in 2000. According to the manufacturer of Da Vinci Surgical robots, Intuitive, more than 1,371 hospitals in the United States have purchased a da Vinci system. A number of facilities have purchased 2 or more units. It is estimated that nearly half a million procedures, worldwide, are performed with the use of a surgical robot each year. Procedures including prostatectomies, hysterectomies, laparoscopies and many other common procedures are assisted by the robot with the promise of better medical outcomes.
Despite being on the market for less than 15 years, da Vinci surgical systems are extremely widespread and have been adopted by most major medical facilities. Part of the reason behind the rapid ascent of the tool are what critics characterize as “aggressive” marketing tactics. Other critics charge that doctors do not receive sufficient or adequate training in the use of the surgical tools. Still others assert that the injuries caused by Da Vinci surgical robots are significantly underreported.
What is a Da Vinci System and What Benefits are Promised?
A da Vinci system is typically comprised of a surgical console that is present in the same room as the patient and a patient side-cart that is equipped with four robotic arms. The robotic arms are controlled from the surgical console.
- Jointed-wrist design permits for a greater range of motion than the human hand can allow.
- Motion scaling and tremor reduction features can refine the movements of the surgeon.
- Improvement over conventional laparoscopy that eliminates the need for camera repositioning and provides greater ease of use.
- Superior imaging and visualization abilities
These improved abilities should allow more physicians to improve minimally invasive surgical procedures thus leading to greater comfort and convenience for the patient. Permitting more minimally invasive procedures should improve medical outcomes by reducing the trauma sustained by the body by reducing pain and blood loss. Use of the machines should allow for shorter hospital stay and improved recovery times.
What Types of Da Vinci Injuries Have Occurred?
Consider the injuries and medical ordeal suffered by Fred E. Taylor after going in for a routine prostatectomy. Mr. Taylor was 67 years old and was apparently in relatively good health. As originally reported by the New York Times, the operation was slated to take 5 hours. However the procedure took more than 13 hours. When the procedure was completed it became clear that Mr. Taylor had been left with an array of serious injuries. Mr. Taylor was left with kidney and lung damage and required the use of a colostomy bag. Furthermore the surgery caused incontinence in Mr. Taylor. According to his wife, the injuries inflicted were so severe that Mr. Taylor would cry about being, “trapped in this body.” Other injuries associated with the da Vinci surgical system include:
- Loss of dangerous amounts of blood
- Cut, tear or puncture of organs, blood vessels or nerves
- Loss of a surgical tool in the patient’s body
- Collapsed lung or pneumonia
- Breakdown and release of muscle fiber
- Kidney damage or failure
- Neuropathy or other nerve damage
The foregoing captures only the more common of surgical injuries. A broad array of other problems are also possible.
Da Vinci Injuries and Deaths May Be Significantly Underreported
However despite the promise of these benefits, there is evidence that the injuries caused by da Vinci systems are being significantly underreported. While there is a federal requirement that makes the reporting of surgical incidents to the FDA within 30 days mandatory, it is not clear that this requirement is always being followed. In fact, the New York Times found a number of reporting lapses regarding problems with the robotic surgery system. These problems include:
- Erin Izumi suffered damage to her colon and rectum following robotic surgery to treat endometriosis. She was hospitalized for 5 weeks. No report was filed regarding the injury.
- Researchers at John Hopkins identified unreported surgical injuries by combining news reports and court records.
- There is no enforcement mechanism to force doctors and hospitals to disclose accidents and injuries.
A 2010 web-based survey sent to urologists who have performed robot-assisted radical prostatectomy (RARP) revealed that more than half have experienced an irrecoverable system failure while performing surgery. Nearly 60 percent of respondents had experienced at least one instance where the medical device failed prior to the commencement of the RARP. Problems with the da Vinci technology may be more severe and widespread than official reporting would lead one to believe.
Rely on our Defective Product and Medical Malpractice Experience
The experienced defective product and medical malpractice attorneys of Reiff & Bily have been trusted by Philadelphians and Pennsylvanians for more than 30 years. Our attorneys handle every step of your injury claim and advocate tirelessly on your behalf. To discuss your legal options following a severe da Vinci surgical injury or the wrongful death of a loved one, call (215) 274-0072.