A WOMAN has died after a surgical robot had “burnt a hole in her intestine” causing a fatal internal leak.
Sandra Sultzer, 78, from Boca Raton, California died in 2022 following an operation to treat her colon cancer using da Vinci robot a year prior.
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The four-armed device is activated by a doctor via camera while a surgeon uses a joystick and foot pedals to control the robot’s arms from a console.
But the lawsuit claims that an electricity leak occurred when the robotic arms were cutting through the patient’s bodily tissue.
According to the plaintiff, a stray electrical energy coming from the machine’s arms burnt Sultzer’s internal organs without the surgical team’s knowledge.
And this isn’t reportedly the first instance in which da Vinci robots have caused unjustified harm to patients.
The lawsuit further stated that Intuitive Surgical Inc – the company that created the gadget – has received “thousands of injury and defect reports”.
Sultzer went under the knife in 2021 at Baptist Health Boca Raton Regional Hospital to treat her colon cancer.
The operating doctors there used the da Vinci robot – a freestanding device with four arms.
A surgeon puts fingers into small loops sets in the console to control the three “hands” while the fourth arm holds the camera.
Each arm is equipped with surgical instruments such as forceps, scalpels and scissors which allow it to make precise incisions the size of a dime.
The gadget’s precise movements supposedly cause less damage to the operative site and less blood loss compared to an open surgery involving a wider cut.
The arms are also wrapped in small rubber sleeves to stop the electricity from leaking to parts of the body.
But the lawsuit claims that the sleeves had cracks in them which caused electrical currents to escape.
The lawsuit alleges that Mrs Sultzer had a hole burnt in her small intestine as a result of this fault.
The burn caused by arcing—a phenomenon in which electricity radiates out—went unnoticed as it was outside the doctor’s area of vision.
A hole in the small intestine could release digestive enzymes and bile which might cause infection and result in a patient having septic shock.
The lawsuit said: “Had ISI 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 small intestine injury to Mrs. Sultzer would not have happened, and she would not have died.”
The lawsuit not only blamed the defective gadget, but it also claimed that the company failed to sufficiently train doctors on how to use it properly, increasing the risk of a possibly deadly surgical error.
The Food and Drug Administration has received several reports of issues and defects about the multi-million machine.
Those reports claim that “the most dangerous injuries arose from burns to internal organs caused by the discharge of electricity, caused by the robot’s instruments inside the patient.”
The da Vinci robots have reportedly been utilised in over 12 million treatments with remarkable success, according to Intuitive Surgical.
Meanwhile, over 20,000 unfortunate cases related to da Vinci were registered with the FDA, reported NBC News.
Over 2,000 incidents involved injuries, with 274 cases resulting in death.
And 17,000 device malfunctions were recorded with incidents spanning from small bugs to serious problems like robots arms deviating off course.
In some instances, the insulation inside patients’ bodies became loose.
When the FDA investigated the mounting issues with the robots in 2013, they found that ISI hid information from the FDA about the defective parts and secretly recalled them.
The company also “ignored known injuries to patients in its design process of critical da Vinci instruments.”
In 2023 alone, the number of incidents related to the da Vinci robot amounted to 3,098, reported the Sun-Sentinal.
ISI told NBC in 2018: “Our training, systems and technologies reflect, and are informed by, our commitment to patient safety, so we offer a comprehensive, intensive training program on our technology that depends on the surgeon’s capabilities — and we also strongly recommend they continue training throughout their careers.
“As with any medical device manufacturer, we are only permitted to train on our technology — we cannot, by law, train on clinical practice or the clinical application of our technology.”
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