Da Vinci Robot Injury Lawyers
Da Vinci Surgical Robot Serious Injuries
The da Vinci Surgical System, manufactured by Intuitive Surgical, Inc., is a complex robotic system which uses multiple arms under human operation to perform surgeries. Though the robot has been used extensively in hospitals nationwide, it has been linked to a range of risks and has, in fact, caused serious injuries and death. Intuitive Surgical is now facing product liability lawsuits over the defective device.
The law firm of Robinson Calcagnie Robinson Shapiro Davis, Inc. is currently investigating claims of people who have suffered injuries during surgery performed by the da Vinci system. If you or a loved one has experienced any of the following injuries, or others, in relation to a da Vinci Robot surgical procedure, contact us for a free case evaluation today:
- Creation of fistulas between organs
- Damage to other organs, vessels, and/or tissues
- Hematomas or internal bleeding
- Sepsis or infection following robotic surgery
- Emergency surgery to correct issues that arise during da Vinci surgery
About the da Vinci Robot
Intuitive Surgical’s da Vinci Surgical System was cleared by the FDA for use in a number of surgeries, including prostate and gallbladder removal, hysterectomies, heart valve repair and organ transplants. On the market since 2000, the da Vinci allows surgeons to perform these procedures with a three or four armed robot by using hand and foot controls at a computer station. Use of the da Vinci, which is Intuitive’s only product and the only robotic system cleared for soft tissue surgery by the FDA, is intended to allow for faster healing, as the process is supposed to be less invasive than traditional surgery.
Aggressive marketing by Intuitive has made the da Vinci commonplace throughout the U.S. The da Vinci was used in almost 400,000 surgeries last year, with nearly one in four U.S. hospitals having at least one da Vinci system in use.
Dangers of the da Vinci System
The U.S. Food and Drug Administration (FDA) is now investigating the safety of the product, as there has been a surge of reported problems during robotic surgeries. According to the FDA’s medical device database, more than 500 adverse events related to the device were reported since January 1, 2012, including at least five deaths. Patients have reported burns, tears and other injuries to internal organs.
Furthermore, on May 8, 2013, Intuitive issued an “urgent medical device notification” to hospitals regarding a potential issue with the da Vinci surgical robot. Intuitive advised that certain models of the da Vinci monopolar curved scissors have “micro-cracks,” which may create an arc, or a pathway, for electrosurgical energy to leak into tissue and cause a burn injury.
In addition, it is possible that the da Vinci is not sufficiently insulated to protect against electrical current or may provide for too much current during use. A wrongful death lawsuit has already been filed regarding this issue. That lawsuit involves a hysterectomy patient who sustained severe burns to her intestines and arteries when an electrical current jumped from the da Vinci to the patient. The woman died two weeks after the surgery.
A number of other injuries or deaths may be related to the use of the da Vinci. Another hysterectomy patient has filed a lawsuit against Intuitive alleging that the robot’s scissors broke off and became lost during her surgery. As a result, the surgeon had to explore the patient’s abdomen for the broken blade, resulting in a more extensive and invasive procedure than anticipated, as well as greater scarring and an increased risk of death or injury.
The FDA has also received reports of a woman who died during surgery when the da Vinci accidentally nicked a blood vessel and of a man who suffered a perforated colon during prostate surgery.
Hospitals Overestimate Benefits of Robotic Surgery
According to a Journal for Healthcare Quality study entitled “Robotic Surgery Claims on United States Hospital Websites,” U.S. hospital websites, and other material they may provide, not only overestimate the benefits of robotic surgery, but largely ignore risks and are greatly influenced by the device manufacturer.
A systematic analysis of 400 random U.S. hospital websites was conducted in June 2010 on the following factors:
- Location and presence of robotic surgery information on the hospital website
- Use of direct linking to the device manufacturer’s website
- Use of text or images provided by the manufacturer
- Statements of improved cancer outcome
- Statements of clinical superiority
- Mention of specific risks
- Mention of a comparison group for citation of supporting data
Based on this data, the study concluded that 41 percent of hospitals described robotic surgery on their websites. Of these, 73 percent utilized manufacturer-provided text or stock images, 37 percent included robotic surgery information on their homepage, 33 percent linked to a manufacturer website, 86 percent made statements of clinical superiority, including 37 percent describing improved cancer control, and 2 percent described a reference group.
Inaccurate representations of robotic surgery influence patient decisions and may ultimately jeopardize their health and safety.
Holding the Negligent Manufacturer Accountable
To date, at least 26 lawsuits have been filed against Intuitive alleging injuries tied to the da Vinci system. The lawsuits allege that injuries were caused by the defective design of the machine, inadequate warnings and/or a lack of training provided by the manufacturer for surgeons.
If you or a loved one has been harmed by the da Vinci Surgical System, our attorneys can help you seek justice. To discuss your particular situation, call us for a free consultation today at (949) 720-1288.