The Da Vinci Surgical System is a device consisting of four robotic limbs that can be remotely controlled by a surgeon to perform a minimally invasive surgical procedure. In 2000, the FDA approved the Da Vinci Surgical System of use in urological, laparoscopic, gynecologic, and non-cardiovascular thoracoscopic surgical procedures. However, numerous patients have since reported pain and serious injuries after being operated upon with the Da Vinci system. These reports, amongst other complaints, have led to a recall of about 30 da Vinci robots, and a growing class action suit against Intuitive Surgical, the company that created the da Vinci system.
Patients who have been operated on by surgeons using the da Vinci system have experienced a variety of post-surgery complications. These complications may include thermal injury to internal organs caused by an electrosurgical energy leak, surgical burns to arteries, tears or perforations of arteries or organs, and wrongful death.
Organizations such as the American College of Obstetricians and Gynecologists and the Kaiser Foundation have also raised questions about the relative effectiveness of the da Vinci system as compared to traditional surgery. In 2012, the Journal of Clinical Oncology published a study which found that the Da Vinci Robotic Surgical System was about as effective when treating women with endometrial cancer as traditional surgery. The main difference that the study found was the price – being operated on by the da Vinci system cost, on average, $1300 more than traditional surgery.
Moreover, medical associations have raised concerns about the preparedness of surgeons who are using these devices for operations. Some reports suggest that a surgeon cannot be proficient in using the Da Vinci system until after 12 uses for some procedures, and up to 200 uses for others. However, due to the low patient volume of certain institutions, many surgeons will not have the opportunity to achieve the desired level of proficiency.
Litigation on behalf of patients who have experienced any complications as a result of the da Vinci surgical system began in 2012 and is ongoing. The lawsuits allege that alternative, safer designs for non-invasive surgery were available, and are holding Intuitive Surgical, hospitals, and surgeons liable.
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