Modern technological advances in surgical equipment has brought many new devices onto the market. Some devices have the ability to help patients and doctors a great deal, while others have a history of complications and malfunctions, with the potential for serious patient injury.
When defective medical devices are used in the healthcare industry, patients have the right to file Da Vinci surgery lawsuits following any related injury.
Many medical device defects are not known until after an accident occurs because equipment may not be properly tested before it is distributed to hospitals and medical clinics. The DaVinci Surgical Robot has been linked to severe complications and has been targeted by personal injury and product liability attorneys in da Vinci surgery lawsuits due to injury.
Joe Lyon is an experienced product liability lawyer and medical device attorney reviewing surgical injury lawsuits for injured plaintiffs nationwide.
Robotic Surgery Injury
Manufactured by Intuitive Surgery, the Da Vinci Robot Surgical System has been utilized in thousands of American hospitals for hysterectomies, prostate removals and other types of surgery. The system is partially manned with a surgeon using a joystick to guide a robot during the surgery.
But after injuries, reports and complaints say that the system is poorly designed and manufactured. The following complications and side effects have been reported:
- Internal bleeding
- Punctured organs
- Bowel injuries
- Revision surgery
- Wrongful Death
Da Vinci Recall & FDA Warning
After the U.S. Food and Drug Administration (FDA) received thousands of reports of the Da Vinci Surgical Robot malfunctioning—mechanical and software issues—the FDA issued a device recall. The company itself admitted the Da Vinci Surgical Robot malfunctions after reports of “instrument cable breaks.”
Studies indicate that the malfunction risk is low, from around 0.4-2.4 percent of all procedures, though that amounts to hundreds of patients compromised each year. An FDA recall was issued in 2016 after thousands of adverse events from the Da Vinci Surgical System have been reported to the FDA.
Surgical Injury Lawsuits
The Da Vinci surgical robot is manufactured by Intuitive Surgical. The machine is used in various operations, including hysterectomies. The Da Vinci surgeries are marketed as minimally invasive alternatives to a traditional abdominal incision hysterectomy. The Da Vinci process produces less trauma, which allows for a faster recovery time.
Unfortunately, Wrong Site Surgery Lawsuits have been reported. The overuse of robotic surgery in benign cases leads to tissue damage, bleeding, scarring, and other robotic surgery injuries. The risk of these complications is increasing with the growing popularity of robotic surgery. The range of surgical complications has hurried corrective procedures, encouraged by the FDA.
The Da Vinci device performs hysterectomies, among other procedures. A Hysterectomy is the surgical removal of the uterus. It is a very common procedure with over 600,000 performed each year in the U.S. With 90 percent of hysterectomies performed being benign. In some cases the uterus is removed and in others, only partially removed.
There are risks involved in any operation, but particularly with a hysterectomy which affects hormonal balances and the overall health of a patient. Hysterectomy patient complications include:
- Bladder injuries
- Chronic pelvic pain
- Vaginal injuries
- Revision Surgeries
Robotic Surgery Injuries
Healthcare professionals say Intuitive Surgical pressures hospitals into using their technology, and accuses hospital management of not adopting technologically sophisticated tools if they do not use the robot. They also say hospitals and physicians will lose market share if they do not implement robotic tools.
Intuitive Surgical denies that there is a high level of risk related to robotic surgery. However, the over-use of robotic surgery in benign gynecological cases causes problems that may not occur if the surgeries were performed manually. Intuitive Surgical and hospitals are responsible for the complications associated with robotic surgery, and are liable when injuries result.
Why are hospitals using the robot so much? Records show that since 2013, Intuitive has paid over $144 million to doctors and hospitals, ostensibly for education, but some plaintiffs question the overall motivation for using the product and risking the health of patients.
An NBC News look into FDA adverse event reports over the past 10 years was quite telling of the risks. The database showed more than 20,000 adverse events related to the da Vinci robot. The reports were filed by the company itself, hospitals, doctors and patients. The amount of da Vinci robot surgeries performed in the U.S. has increased by over 50 percent since 2013, to nearly 700,000 operations.
More than 2,000 adverse events seen by NBC were categorized as involving injuries, 274 were categorized as deaths. Thousands of Da Vinci device malfunctions were reported, and now hundreds of malpractice and product liability lawsuits are pending.