Tuesday, June 25, 2024

Did A Surgical Robot Caused a Women’s Death?

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Harvey Sultzer is suing Intuitive Surgical for over $75,000 in damages after a da Vinci surgical robot allegedly caused the death of his wife, Sandra Sultzer. The surgical robot reportedly burned a hole in her small intestine during a colon cancer treatment procedure, leading to her eventual demise.

In a heart-wrenching case that has cast a shadow over the promises of modern medical technology, Harvey Sultzer finds himself embroiled in a legal battle against Intuitive Surgical (IS), the maker of the da Vinci surgical robot. His wife, Sandra Sultzer, underwent surgery for colon cancer at Baptist Health Boca Raton Regional Hospital in September 2021, where the da Vinci robot was used.

Intuitive Surgical’s da Vinci system has been marketed for its precision and minimally invasive approach, boasting capabilities beyond human limitations. However, the lawsuit alleges that the device inflicted a catastrophic injury by burning a hole in Sandra’s small intestine, necessitating further medical interventions that ultimately could not save her life.

The case brings to light several alarming accusations against Intuitive Surgical. The lawsuit contends that the company was aware of insulation issues with the da Vinci robot, issues that had been flagged in an FDA investigation from 2009 to 2011, yet failed to adequately warn patients and the public. Moreover, IS is accused of underreporting incidents of injuries and defects associated with the robotic system to the FDA.

This legal action is not an isolated incident for IS, which faced around 93 lawsuits in 2014, as disclosed in reports to the Securities and Exchange Commission (SEC). Many of these lawsuits stemmed from surgeries utilizing the da Vinci Surgical System, which resulted in personal injuries and, in some cases, death.

The lawsuit also critiques IS’s practices of selling the da Vinci robots to hospitals with insufficient experience in robotic surgery and not ensuring surgeons complete the necessary training to operate the device safely. Despite offering a training program, Intuitive Surgical does not have the authority to require surgeons to complete it, revealing a significant gap in ensuring patient safety.

Why It Matters

This tragic incident and subsequent lawsuit underscore the critical need for rigorous safety standards, transparency, and accountability in the use of advanced medical technologies like a surgical robot. It highlights the potential risks associated with these devices and the importance of thorough training for surgeons to prevent future tragedies.

Potential Implications

The outcome of this lawsuit could have far-reaching implications for the medical technology industry, possibly leading to stricter regulations on robotic surgery devices, improved training protocols for surgeons, and greater transparency regarding the risks associated with such technologies.

Source: WION

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