Complications from the da Vinci Surgical Robot
In 2000, Intuitive Surgical, Inc. gained FDA approval for their surgical robot, da Vinci. The device was intended to revolutionize the way surgeries were performed and minimize recovery time for patients. However, design flaws and technical issues with the robot during surgeries have led to a number of injuries and even death.
What is the da Vinci Surgical Robot?
Intuitive Surgical marketed the robot as a less invasive, more cost effective, and faster way to perform laparoscopic, urologic, and gynecological surgical procedures. The device uses a small incision during a procedure, which should result in less risk of excessive blood loss and less time to heal. The da Vinci robot was intended, essentially, to be a precision tool to provide well-trained doctors with a more appealing surgical alternative for patients.
Complications with Surgical Procedures
Not long after the da Vinci system received FDA approval, problems with the machine arose. A number of post-surgical procedure complications were observed, including patients experiencing burns, punctures in tissue and organs, and internal bleeding. Many of these complications went undetected for a substantial period of time following the surgeries. In some cases, post-surgical excessive bleeding has resulted in death.
Specific complications resulting from the surgical robot include:
- Uterine lacerations
- Punctured vessels and organs
- Intestinal tearing
- Uncontrollable and excessive bleeding
Some patients, their families, and doctors, are now claiming that design flaws within the surgical robot are responsible for the unforeseen complications. Allegations maintain that the tips of surgical instruments attached to the da Vinci robot contain miniscule cracks causing the robot to malfunction. One such alleged malfunction is that electrical currents jump from the instruments, causing sparks, and in effect, electrical burns to the patient.
In July, 2015, researchers from University of Illinois at Urbana-Champaign, the Massachusetts Institute of Technology and Chicago's Rush University Medical Center published a survey detailing the adverse incidents related to the use of surgical robotic devices. The information provided in the survey revealed that in a 14 year period, the devices malfunctioned over 8,000 times, caused more than 1,400 injuries and resulted in 144 patient fatalities. The study notes that the actual number or adverse incidents could be higher, as these results were based on information that was submitted to the FDA.
The Cost of da Vinci
In 2010, studies concluded that not only was da Vinci more costly than other traditional surgical procedures, but that it also required more time and training than Intuitive Surgical had repeatedly promoted. Further research into the device revealed that between 2010 and 2011, the company received over one hundred and thirty complaints from doctors about flaws or problems with the system, of which, only two thirds were reported to the FDA.
Despite the company’s stance that there were no technical flaws with the da Vinci surgical robot, it sent hospitals replacement tips for certain surgical instruments on the device. Intuitive Surgical insisted that these replacements be used immediately in lieu of older versions. Notwithstanding these measures, doctors continued to experience problems with electrical currents arcing from the device.
Allegations and Legal Action
Lawsuits against Intuitive Surgical allege that the company manufactured a defective product, which it failed to adequately test before taking to market. Claims also assert that Intuitive Surgical sold an unsafe product, and failed to warn hospitals and doctors of its risks. The FDA investigated claims regarding the da Vinci robot and concluded that Intuitive Surgical failed to inform the FDA of defective equipment and that Intuitive Surgical misinformed hospitals and doctors about the safety and efficiency of the product. Furthermore, it was discovered that Intuitive Surgical advised hospitals that only three supervised training surgeries were necessary for a physician to be properly prepared to perform unaccompanied surgeries using the da Vinci robot. To the contrary, studies conducted found that a surgeon would need more than 200 supervised surgeries using the da Vinci robot to be qualified to perform unaccompanied procedures using the device.
Attorneys are exploring the prospect of initiating legal action against Intuitive Surgical, Inc. on the basis that the company negligently marketed the da Vinci Surgical robot while being fully aware of the risks associated with the device. If you believe that you may have been harmed while undergoing a surgical procedure using the da Vinci Surgical robot, you should consult The Law Offices of Peter Angelos, P.C.