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A California woman and her husband have filed a product liability lawsuit alleging that problems during a robotic hysterectomy with the da Vinci Surgical System caused damage to her uterer, resulting in a number of painful injuries.
The complaint (PDF) was filed by Elisa Rister and her husband, Richard, in the U.S. District Court for the Northern District of California on July 26.
Intuitive Surgical, Inc., the manufacturer of the da Vinci Surgical System, is named as the only defendant in the lawsuit, which alleges that the company knowingly and aggressively sold the complex robotic surgery machine to hospitals nationwide without adequately researching the product or providing sufficient warnings about the risks and complications associated with the robotic device.
According to the complaint, during da Vinci robotic surgery, Elisa Rister suffered damage to her uterer, which is a tube that moves urine from the kidneys to the bladder. The robot also allegedly damaged her vaginal cuff and bowel during the hysterectomy surgery. She now suffers from abdominal pain, pelvic pain, dysparuenia, bloating, abdominal distention, and has decreased energy and stamina, the lawsuit claims.
Robotic Surgery Complications and Damages
The da Vinci Surgical System is a complex, remote-controlled robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The robot is controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls.
Rister’s complaint is one of a growing number of da Vinci surgery lawsuits filed by individuals throughout the United States who have suffered complications following a robotic hysterectomy or other procedure involving the robot.
The lawsuits involve similar claims concerning design defects associated with the machine, which allegedly may cause individuals to suffer damage to surrounding organs, vessels or tissue during surgery.
The use of monopolar energy to cut, burn and cauterize tissue has been identified as one of the problems with the design of the surgical robot, alleging that safer methods are available, such as bipolar energy and ultrasonic energy, which would reduce the risk of complications. In addition, the complaint indicates that the da Vinci robotic arms have inadequate insulation, allowing electrical current to pass into tissue outside of the operative field.
Following a hearing before the U.S. Judicial Panel on Multidistrict Litigation last month, a request to consolidate all federal da Vinci lawsuits before one judge for coordinated pretrial proceedings was denied. Therefore, all cases pending in U.S. District Courts throughout the country are proceeding as individual claims, although it is expected that there will be informal coordination between the actions to reduce duplicative discovery and avoid conflicting pretrial rulings.