The surgical robot, known as the Da Vinci robot, was first introduced in 1999 as a surgical device with multiple arms. The robot has surgical tools, including forceps, scissors, scalpels and others, which surgeons control from a distance using an onboard camera.
The Da Vinci offers a wide range of clinical applications across specialties such as general surgery, urologic surgery, gynecologic surgery, cardiothoracic surgery and head and neck surgery. Meanwhile, procedures include hernia repair, colon and rectal procedures, cholecystectomy, bariatric surgery, hysterectomy and lobectomy, among others.
Sandra Sultzer chose to allow a Da Vinci robot to be used for her surgery. However, Intuitive Surgical Inc., the manufacturer of the Da Vinci, allegedly failed to warn Sandra about the potential issues of using the robot in her surgery at Baptist Health Boca Raton Regional Hospital in Florida.
According to the lawsuit filed by Harvey Sultzer, husband of the victim, Sandra suffered a "thermal injury" to her small intestine, resulting in a perforation. The lawsuit claims this injury required further medical intervention and caused physical and emotional harm, ultimately leading to her death.
The lawsuit, filed in West Palm Beach in the District Court for the Southern District of Florida, claims that the company neglected to design the product to prevent stray electrical energy from harming patients without the surgeons knowing or controlling it. Additionally, the lawsuit alleges that surgeons weren't adequately trained to use the device.
Furthermore, the case states that most of the Da Vinci robot's instruments are disposable, leading to the company relying on the Da Vinci being used in more surgical procedures than is necessary for the company to make back what it invested in its creation. And, in turn, they sell their surgical instruments to hospitals lacking experience in robotic surgery. These hospitals depend solely on the company to train their surgeons on how to use these instruments.
Da Vinci robot linked to thousands of injuries and hundreds of deaths
The controversy surrounding Intuitive Surgical, Inc. is not new, and unfortunately Sandra Sultzer's injury and subsequent passing are not isolated cases.
The Da Vinci has been linked to thousands of complaints regarding burns and injuries, safety issues and negligence. As of now, Intuitive Surgical is named as a defendant in approximately 93 product liability lawsuits.
In 2018, NBC News reported that over 20,000 adverse events related to the Da Vinci had been filed in the Food and Drug Administration's (FDA) MAUDE database over the past decade, including nearly 17,000 device malfunctions, over 2,000 injuries and 274 deaths.
The most dangerous problems were burns to the organs inside the body, which happened because of electric discharges from the robot's tools during surgery. (Related: Surgical robots are impossible to clean, all machines contaminated.)
For instance, in that same year, a woman from Iowa suffered from burns and damages during a Da Vinci-assisted hysterectomy. More than a dozen patients also claimed injuries during surgeries involving the Da Vinci device.
Moreover, the FDA conducted an investigation with Intuitive Surgical in 2013 after the company received thousands of injury and defect reports. The FDA sent a warning letter to the manufacturer, accusing it of concealing information, secretly recalling defective parts and disregarding known injuries in the design process.
Learn more about the dangers of using robots at Robotics.news.
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