A surgical robot burned a hole in a Florida woman’s small intestine during surgery and led to a fatal internal leak, a lawsuit filed by her husband claims.
Sandra Sultzer, 78, of Boca Raton, died in 2022 after a procedure to treat her colon cancer last year, which was performed using a “da Vinci” robot.
The four-armed machine is activated by a doctor operating a camera and a surgeon manipulating the robot’s arms from a console using a joystick and foot pedals.
But the lawsuit alleges that a mistake released electrical energy from the robotic arms used to cut body tissue and burn her internal organs without the surgical team’s knowledge.
The da Vinci robot is a free-standing cart equipped with four arms. One arm holds a camera or laparoscope and the surgeon controls the other three ‘hands’ by inserting their fingers into small sets of loops
Doctors who perform the operation using the robot operate the arms from behind a console
The lawsuit added that this is not the first time da Vinci robots have caused unnecessary damage. The company behind the device, Intuitive Surgical Inc., “has also received thousands of reports of injuries and malfunctions.”
Sandra Sultzer had surgery at Baptist Health Boca Raton Regional Hospital in September 2021 to treat her colon cancer.
Surgeons there used the da Vinci surgical robot, a free-standing cart with four arms.
There is a camera, or laparoscope, in one arm, and the surgeon controls the other three ‘hands’ by putting their fingers in small loops behind a console.
Each arm is equipped with tweezers, scissors, scalpels and other surgical tools, and can make incisions the size of a dime.
The precise movements usually result in less blood loss and trauma at the surgical site than open surgery with a larger incision.
The arms are wrapped in small rubber sleeves to prevent electricity from leaking to parts of the body outside the very precise surgical site, but the lawsuit claims there were tears in the sleeves that allowed electrical currents to escape.
This, the lawsuit alleges, led to a hole being burned in Ms. Sultzer’s small intestine.
The burn caused by the radiating electricity, also called arcing, occurred outside the doctor’s field of view and therefore went unnoticed.
A hole in the small intestine releases digestive enzymes and bile, which can lead to infection. If that infection spreads, the person may go into septic shock.
The lawsuit stated, “If ISI had safely designed its product so that stray electrical energy would not burn the insides of patients without the knowledge or control of the operating surgeons, the injury to Ms. Sultzer’s small intestine would not have happened, and she also not. have died.’
In addition to alleging product defects, the lawsuit alleged that the company failed to adequately train physicians in the effective use of the device, increasing the chance of a potentially fatal error during surgery.
The robot’s arms are wrapped in rubber covers to prevent electricity from radiating out. But thousands of medical device reports to the FDA have found cracks or crevices in those covers, meaning electrical currents can leak to external tissues.
This is far from the first time issues with defective rubber boots have been raised.
Among the reports of problems and defects to the Food and Drug Administration about the multimillion-dollar robot, “the most dangerous injuries resulted from burns to internal organs caused by the discharge of electricity caused by the robot’s instruments into the patient.”
Intuitive Surgical said the da Vinci robots have been used with overwhelming success in approximately 12 million procedures.
But at the same time, more than 20,000 adverse events related to the da Vinci were filed with the Food and Drug Administration between 2008 and 2018, according to an analysis of medical device reporting data by NBC News.
More than 2,000 registered incidents involved injuries, with 274 incidents resulting in fatalities.
In addition, nearly 17,000 events were identified as device failures, ranging from minor failures to more serious issues, such as uncontrolled robotic arms becoming loose and cases of insulation becoming loose in patients’ bodies.
The FDA in 2013 investigated mounting reports of problems with the robots and found that the company had “hid information from the FDA, secretly recalled defective parts, and ignored known patient injuries during the design process of critical da Vinci instruments.” .’
The Sun-Sentinal reported that in 2023 alone, the number of adverse events related to the da Vinci device recorded in the database totaled 3,098.
Intuitive Surgical did not respond to a DailyMail.com request for comment, but told NBC in 2018: ‘Our training, systems and technologies reflect and are informed by our commitment to patient safety, so we provide a comprehensive, intensive training program in the areas of patient safety. our technology that depends on the surgeon’s capabilities – and we also strongly encourage them to continue training throughout their career.
‘As with any medical device manufacturer, we are only allowed to train in our technology. We cannot legally train in the clinical practice or clinical application of our technology.”