The introduction of the da Vinci was supposed to usher in a new era of safer, more convenient surgical procedures. However, this device has created a number of complications for patients and is now the subject of multiple lawsuits.
What Is the Da Vinci?
The da Vinci is a high tech robotic surgery system manufactured by Intuitive Surgical as an alternative to laparoscopic surgery. First introduced in 2000, it is used to perform a variety of surgical procedures, including heart procedures, gynecological surgeries, and prostate cancer removal surgery. Ideally, using the device benefits the patient by providing a minimally invasive procedure with less pain and faster recovery time.
There are an estimated 2,500 da Vinci systems in hospitals and surgical suites, valued at over $1.5 million each. Over 600,000 people had da Vinci surgical procedure in 2015 alone.
The Problems Associated With the Da Vinci
When it was introduced, the da Vinci was advertised as the future of modern medicine. Promotional videos showed the robot peeling a grape and folding origami to demonstrate its impressive capabilities, while failing to convey the possible risks involved with this medical device.
There is evidence to suggest the da Vinci may create sparks during a malfunction that causes electric currents to leak out of the robot while it's being used. This arcing electricity can result in patients experiencing perforated intestines, prostate and vaginal injuries, painful abscesses, and serious infections.
Other reported complications related to the use of the da Vinci system include:
- Severed nerves
- Bowel perforations
- Torn organs
- Inflammation or infection in the stomach lining
- Burns caused by surgical instruments
- Excessive bleeding
According to the U.S. Food and Drug Administration (FDA), some of the problems associated with the device include:
- The company provided the wrong instructions regarding accessories and generators.
- The instruction manual didn't provide vital information about inspecting, flushing, and transporting the da Vinci robot.
- The device was promoted for use in thyroid surgeries, even though it was never cleared for this purpose.
- The device had damaged tip covers that injured multiple patients.
- The original manual stated the device could be used for transoral surgeries on pediatric patients, but this recommendation was reversed.
A 2010 study of robotic surgical systems found that a surgeon would need to conduct between 150 and 250 procedures before developing the level of skill necessary to operate the device safely. However, sales representatives for Intuitive Surgical often pressured hospitals to allow surgeons to operate the device with minimal training. One hospital was pressured to reduce its requirement that a surgeon perform five supervised surgeries before being allowed to operate the da Vinci independently.
What Are the Allegations Against Intuitive?
Intuitive is the defendant in several product liability complex litigation claims involving the da Vinci robotic surgery system. The lawsuits against Intuitive accuse the company of:
- Manufacturing an unsafe product
- Failing to test the machine before selling
- Not providing the correct training to hospitals and the surgeons who would be using the da Vinci robot
- Neglecting to implement a monitoring system for reporting complications
- Continuing to sell the da Vinci even after it was known that the robot wasn't safe for use
To date, the resolved Intuitive cases have all involved settlements for an undisclosed sum, including:
- Michelle Zarick was injured during a routine hysterectomy in 2009 and had originally asked for $30 million in damages.
- Patricia Mayfield sued after developing a painful abscess following a da Vinci hysterectomy in 2010.
- Jennifer Silvestrini was injured during a da Vinci assisted thyroid procedure after the device malfunctioned while in her neck.
We Can Help
If you or a loved one experienced complications after a da Vinci surgery, you may be eligible for compensation. Damages may be awarded for lost earnings, medical expenses, and pain and suffering. To win your case, you must be able to prove that your injuries were caused by the robotic surgery system and not by a surgeon's error. Having a skilled attorney on your side is a must if you believe you've been hurt by the da Vinci robotic surgery system.
The dedicated attorneys at Neblett, Beard & Arsenault are committed to protecting the rights of patients who’ve been harmed as the result of a da Vinci robotic surgery procedure. Schedule a free consultation. You can complete our online form or call us directly at 800.256.1050.