Da Vinci Surgical Robot
Da Vinci Surgical Robot Linked to 5 Patient Deaths
ATTENTION: A number of lawsuits have been filed against Intuitive Surgical, Inc., maker of the da Vinci surgical robot. The da Vinci device, used commonly in gall bladder removal, gastric bypass, and thyroid removal procedures, has been linked to serious injuries and at least 5 patient deaths.
DA VINCI SURGICAL PROCEDURE INJURIES
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 U.S., 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
NEARLY 400,000 DA VINCI SURGERIES PERFORMED LAST YEAR
- The da Vinci robot was reportedly used in 400,000 surgeries in 2012.
- Nearly 1 out of 4 U.S. hospitals (approximately 1,400) have at least one da Vinci system.
- According to Intuitive Surgical Inc., the number of robotic surgeries has tripled in the last four years.
- The da Vinci is commonly used for prostatectomies (prostate removals) and hysterectomies but has also been used in:
- Gastric bypass surgery
- Gall bladder removal surgery
- Thyroid cancer surgery
- Cardiac operations
- Head and neck procedures
FDA INVESTIGATES DA VINCI SURGICAL ROBOT
Earlier this year, the FDA began investigating the da Vinci Surgical Robot after an increase in adverse events were reported to the agency. According to the FDA’s MAUDE reporting database, the number of Adverse Event Reports (AERs) increased 34% between 2011 and 2012.
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