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The da Vinci Surgical System: A Web of Controversies

da Vinci Surgical System, da Vinci robot, Intuitive Surgical, minimally invasive surgery, MIS, medical malpractice, surgical mistakes, malfunction, Sultzer case, Sandra Sultzer

 

The da Vinci Surgical System

Manufactured by Intuitive Surgical, has revolutionized surgery since its introduction in the late 1990’s. Touted for its precision and minimally invasive approach, the robot-assisted surgical system promised a revolution in medical procedures. However, its journey has been riddled with controversy, leading to a mixed reception among medical professionals. And a series of legal battles stemming from patients’ injuries, deaths, and malpractice claims.

Palm Beach claim just latest in suits filed against Intuitive Surgical

According to a recent suit filed in the U.S. District Court in West Palm Beach, an electrical arc from a da Vinci Surgical System robot burned a Palm Beach County woman’s small intestine during a colon cancer procedure, and the error caused her death.

The suit, filed by Harvey Sultzer of Delray Beach, claims that Intuitive Surgical failed to warn his wife Sandra of issues that could have caused her to decline use of the company’s da Vinci surgical robot for a procedure she underwent in 2021. The lawsuit also says the company failed to safely design the product and failed to properly train surgeons on how to use it. When Sandra Sultzer underwent surgery at Baptist Health Boca Raton Regional Hospital, she experienced “thermal injury (to her) small intestine, causing a perforation which required subsequent medical intervention and caused physical and emotional injury, and ultimately her death,” the lawsuit claims.

A Technological Leap with Questionable Benefits

Introduced in 1999, the da Vinci Surgical System marked a significant milestone in the evolution of surgical technology. If offered minimally invasive surgery (MIS) with enhanced precision, flexibility, and control. Consisting of a console operated by a surgeon, a cart with robotic arms, and a high-def 3D vision system. The da Vinci’s introduction was seen as the beginning of a new era in surgical procedures, with potential benefits including reduced pain, shorter hospital stays, and quicker recovery times for patients.

Despite its promise, questions about cost-effectiveness and long-term outcomes have haunted the technology. Concerns about patient safety and the adequacy of training for surgeons lingers. Critics argue that the steep learning curve and lack of standardized training protocols increase the risk of surgical errors. The high cost of the robot, resulting in increased healthcare costs with no definitive proof of superior patience outcomes compared to traditional laparoscopic surgery has also raised red flags.

Where do Medical Professionals Stand?

The medical community’s response to the da Vinci Surgical System has been mixed, at best. Some surgeons champion the technology for its advantages in specific types of surgeries, such as prostatectomies and hysterectomies, as its precision can significantly improve outcomes. Others, however, remain skeptical, citing the lack of strong evidence for improved outcomes and high costs. Concerns over cost-effectiveness and the system’s steep learning curve add more controversy to the debate.

The Legal Implications

From a legal perspective, the issues surrounding the da Vinci System encompass BOTH medical malpractice and product liability issues, and patients who have suffered injuries allegedly due to the system have pursued legal action on both grounds. To provide some perspective, in 2014, Intuitive set aside $67M to settle roughly 3,000 claims dating back to 2012 related to the da Vinci System. After extensive mediation, the company settled because it was more cost-effective than going to litigation.

Many of the recent da Vinci settlements have come from malpractice suits against surgeons. In 2021, for example, a 56-year-old man received a $700,000 settlement after he sued his surgeon for cutting a hepatic duct during a gallbladder procedure.

The majority of plaintiffs involved in litigation against Intuitive complained of injuries due to equipment malfunctions that caused leaks of electrical currents and arcing, a situation that results when sparks from a surgical instrument land in a patient’s body, causing burns. Plaintiffs allege that they experienced perforations, infections, abscesses, and other heat-related damage that required additional procedures to correct.

Lawsuit claims the tragedy should have been avoided

According to the Sultzer lawsuit, the electrical arcing resulted due to cracks in the rubber sleeves that are wrapped around the arms of the device to prevent electricity from leaking to areas of the body outside of the surgical site. The burn happened outside the doctor’s field of vision, going unnoticed. The resulting hole in the small intestine released digestive enzymes and bile, which led to the infection. According to the law firm representing the Seltzers’:

“Had the defendant designed its product so that the 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 Future of Robotic Surgery

The controversies and legal battles surrounding the da Vinci Surgical System underscore the complex relationship between innovation, patient safety, and accountability in the healthcare industry. As robotic surgery evolves, it is imperative for regulatory bodies, medical institutions, and manufacturers like Intuitive surgical to address these challenges proactively. This includes implementing comprehensive training programs, conducting rigorous safety evaluations, and being transparent about the risks and benefits of robotic-assisted procedures.

For personal injury law firms representing clients in cases against Intuitive Surgical or healthcare providers, these incidents highlight the need for a nuanced understanding of medical technology, surgical procedures, and the legal frameworks governing medical malpractice and product liability. The goal is not only to seek justice for the individuals who have suffered due to these technologies, but also to ensure that innovations like the da Vinci Surgical System genuinely serve the best interests of patients, enhancing the safety and efficacy of medical care in the process.

Do you have a loved one who has been hurt due to a potential medical malpractice or product liability issue? The expert personal injury lawyers at GOLDLAW will thoroughly investigate the details of you case and work alongside you to find the best legal strategy to obtain the most compensation possible for the injuries suffered. For a FREE consultation, tell us about your case here, or “choose the 2’s,” and call us at 561-222-2222 to get started today!