da Vinci Surgical Robot
HAVE YOU SUFFERED COMPLICATIONS FOLLOWING ROBOTIC SURGERY?
A number of lawsuits have been filed against Intuitive Surgical, Inc., maker of the da Vinci surgical robot. The da Vinci is commonly used for prostatectomies (prostate removals) and hysterectomies but has also been used in gastric bypass surgery, gall blader removal, thyroid cancer surgery, cardiac operations, and head and neck procedures.
The da Vinci is a robotic surgical system that is controlled by a surgeon via console controls. The system is designed to perform surgery using a minimally invasive approach and has been hailed as a revolutionary improvement to traditional laparoscopic surgery.
Unfortunately the system, which is used in hospitals across the United States, has been blamed for numerous surgical mishaps, serious injuries, and patient deaths. More than 500 da Vinci incidents have been reported by the FDA since January 2012. Injuries include:
- Tissue inflammation
- Excessive bleeding
- Punctured blood vessels, organs or arteries
- Severe bowel and intestine injuries
- Correction surgery
- Follow-up surgery
- Wrongful death
According to Intuitive Surgical, as of September 2016, there are more than 3,800 da Vinci systems installed in hospitals around the world. More than three million patients worldwide have been operated on with a da Vinci robotic system.
da VINCI SURGICAL ROBOT LINKED TO ADVERSE EVENTS
In July 2014, the Food and Drug Administration (FDA) warned Intuitive Surgical that there would be equipment seizures and fines if the company did not correct alleged violations regarding the da Vinci surgical system. The FDA claimed that the company was not adequately reporting adverse events caused by the robotic system.
A review of FDA data regarding these adverse events revealed that 71 deaths and 174 serious injuries were associated with the da Vinci surgical system. A surgeon who contributed to the review said the current FDA self-reporting system is “haphazard and inconsistent.” In addition, a 2014 study suggested that the use of the da Vinci surgical robot for ovarian cyst removal could result in more complications than ordinary minimally invasive techniques. Other studies showed that surgery with the da Vinci system offered no significant improvement over traditional laparoscopic approaches to other surgeries, including gallbladder removal and colorectal surgery.
da VINCI RECEIVED PREMARKET APPROVAL
The da Vinci surgical robot system received FDA approval in 2000 through a controversial process called “premarket notification,” often used to permit medical devices to be used without the typical rigorous testing required of new drugs. A number of lawsuits have been filed on behalf of da Vinci patients alleging:
- Improper training for surgeons
- Defective product design
- Equipment malfunction
- Improper marketing tactics
CONTACT AN EXPERIENCED DEFECTIVE MEDICAL DEVICE LAWYER TODAY
If you or a loved one have been injured after undergoing a medical procedure performed with a da Vinci surgical robot system, contact Thomas J. Henry immediately. Our experienced defective medical device and dangerous drug attorneys are available 24/7, nights and weekends to take your call and evaluate your claim. Call us today for a free case review.