- International surgical robotics market size was valued at $9.6 billion in 2021 and is expected to to reach $25.47 billion by 2030 at a CAGR of 15.4 percent from 2023 to 2030
- As per reports filed to FDA's Manufacturer and User Facility Device Experience (MAUDE) against Intuitive, 2000 reports stated grave injuries, and 274 related to death.
The da Vinci surgical robots found themselves back in the spotlight, facing what seems like another round of "media trial" after a lawsuit was filed by Harvey Sultzer, the husband of the late Sandra Sultzer, against the device's maker, Intuitive Surgical. Renowned for its precise accuracy "beyond the limits of the human hand," the da Vinci surgical robot encountered controversy when Sandra, admitted to Baptist Health Boca Raton Regional Hospital in 2021, suffered a torn and burned small intestine during a 2022 operation.
Media reports detailed Sandra's post-surgery complications, including fever and abdominal pain, leading to further procedures to heal her intestinal wound. The lawsuit alleges the company's recklessness and device malfunction caused Sandra's demise, pointing to Intuitive Surgical's prior knowledge of insulation issues potentially leading to electrical disruptions and subsequent intestinal burns.
Furthermore, allegations surfaced regarding Intuitive's sales practices, including supplying medical robotic devices to inexperienced nursing homes and surgeons lacking proper training. NBC News Investigations highlighted instances where Intuitive's training program was non-mandatory, potentially contributing to surgical mishaps.
This isn't the first time medical robots have made headlines for all the wrong reasons. In a UK hospital in 2018, a robotic device damaged a patient's heart valve, resulting in fatality, and even in the US, incidents of grave injuries and deaths related to da Vinci robots have been reported, with over 20,000 such incidents documented in the FDA's MAUDE database.
Highlighting the causes and the challenges, Yogesh Bawane, Robotics/STEM Educator and Executive Product Head at Robo Champs told Circuit Digest, “In the vast landscape of medical and surgical robotics, both in India and around the globe, we are constantly navigating a tightrope between innovation and safety. The challenges are multifaceted - from ensuring the absolute reliability of our devices to grappling with the regulatory nuances that safeguard patient well-being. Every incident of a robot causing harm, such as the tragic case in the US, underscores the imperative need to prioritize safety above all. These incidents often stem from a complex interplay of technological glitches, such as insulation failures leading to catastrophic outcomes. It's a stark reminder that behind every device we develop and deploy, there are human lives at stake.”
According to the National Library of Medicine, in the past 10-15 years, 144 deaths, 1,391 patient injuries, and 8,061 robotics device malfunctions were reported. Medical robots, which are mostly used for gynecology and urology, witnessed a low volume of injuries and death as compared to the complex surgeries. In spite of these grave incidents, Meticulous Research highlighted that the international surgical robotics market size was valued at $9.6 billion in 2021 and is expected to to reach $25.47 billion by 2030 at a CAGR of 15.4 percent from 2023 to 2030. North America dominated the surgical robotics market, with 70.7 percent in 2021, while the Asia Pacific region is expected to register the highest CAGR of 7.1 percent during the forecast period.
“Despite the hurdles, the horizon of medical robotics is expanding at an exhilarating pace. The promise of less invasive procedures, precision, and quicker recovery times continues to fuel our collective drive towards innovation. As we stand on the cusp of this technological revolution, the growth we are witnessing is not just in market share but in the potential to transform lives,” added Bawane.
