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Da Vinci Surgical Robot Lawsuit Alleges Serious Injury, Additional Surgery

A plaintiff brought a da Vinci surgical robot lawsuit in California, alleging the device caused severe injury during his prostatectomy that led to ongoing pain, suffering and the need for additional surgery. The complaint alleges that the manufacturer of the device failed to include proper warnings about the risks.

Lawsuit joins other litigation across the country

David Kuni filed his da Vinci surgical robot lawsuit on June 28, 2013, in U.S. District Court for the Northern District of California. Last year, plaintiffs moved to have similar lawsuits involving the da Vinci robotic system centralized in this court to help expedite pretrial discovery and other proceedings. However, that motion was denied, even as plaintiffs continue to file individual lawsuits against da Vinci manufacturer, Intuitive Surgical.

In this complaint, Kuni states he underwent a da Vinci prostatectomy on July 29, 2010. Kuni opted for this procedure based on the advice of his physician and literature from Intuitive touting the benefits of robotic surgery over traditional surgical methods. According to his complaint, those recommendations gave Kuni the impression robotic surgery would provide a better outcome, less pain and a faster recovery time.

A prostatectomy is a procedure used to treat urinary incontinence caused by an enlarged prostate. The most common option is to remove the portion of the prostate gland that is directly contributing to the incontinence issue – a procedure known as an open prostatectomy. This procedure may be performed traditionally through an incision below the navel. It may also be done laparoscopically using smaller incisions, or with the assistance of a device like the da Vinci robot.

Lawsuit alleges multiple da Vinci robot prostatectomy problems

Kuni states in his complaint that he experienced problems during his procedure and long after. According to the complaint, his robotic surgery resulted in serious damage that included a large rectal laceration. The problems were addressed through intraoperative repair with sutures, as well as a loop ileostomy. An ileostomy is a procedure used to remove waste from the body through a pouch attached to the small intestine. It is performed when the colon or rectum is not functioning properly and waste must be diverted through others means.

In his da Vinci surgical robot lawsuit, Kuni states he had to undergo an additional procedure to remove the ileostomy bag and eventually developed a hernia at the site of his ileostomy incision. He continues to require medical treatment for his injuries, which has included multiple surgical procedures. He also suffers from persistent abdominal pain, incontinence and scarring.

About the da Vinci robot

The da Vinci robot was approved by the FDA in 2000 for use in specific surgical procedures. The robot was designed to assist the surgeon’s hands, creating a more precise, controlled surgical procedure.  Since the device was introduced in the U.S., serious robotic surgery complications and injuries have been reported. These include organ lacerations, surgical burns and torn blood vessels. Some patients have required multiple procedures to repair the damage. A few have died from their injuries.

The FDA continues to monitor these reports at this time. In July, 2013, the agency issued a Class II recall of 30 da Vinci devices, citing failure to test the devices in accordance with agency standards. The FDA also cited the company in June, 2013, for promotional literature touting the benefits of the device for a thyroidectomy, which had not been approved.

While the FDA continues to keep a watchful eye over the situation, lawsuits continue to be filed against Intuitive Surgical. Kuni lists a number of counts against the company in his complaint, including product liability, negligence and breach of warranty. He is seeking compensatory and punitive damages from the company to compensate for his pain and suffering, ongoing medical treatment and lost wages.