Since coming onto the market in the 1980s, doctor-controlled robots have been hailed as one of the next big advances in surgery. The da Vinci Surgical System, manufactured and sold by Intuitive Surgical, has steadily grown in popularity in recent years. Over 2,000 hospitals now have at least one surgical robot, and in 2012 the da Vinci robot was used in some 200,000 surgical procedures. However, recent reports of mechanical complications and patient injuries have led to renewed scrutiny on the proper use of the da Vinci surgical robot.
The da Vinci Surgical System consists of multiple mechanical arms and a nearby console. Surgeons remain seated at the console, using its high definition, three dimensional view system and state of the art instruments to operate on patients. These features offer a number of advantages:
Intuitive Surgical claims that these features make surgeries less invasive, resulting in less blood loss and shorter recovery periods for patients.
Due to its viewing system and mechanical arms, surgical robots are often used for procedures in small, hard to reach areas. Surgeons frequently use the da Vinci Surgical system for hysterectomies, gallbladder removals, heart surgery, weight loss surgeries, and organ transplants. Some estimate that robots are used in 85% of all prostate removal surgeries conducted in the United States. Future uses of surgical robots may include treating cancer in the head and neck.
The growth of robotic surgery has led to an increase in reports of injuries linked to da Vinci Surgical systems. The Food and Drug Administration (FDA) tracks reports of medical device problems, including injuries and malfunctions related to robotic surgery. Common mechanical problems reportedly include malfunctioning arms, control freezes, and electrical problems. In some cases, surgical systems have had to be restarted during surgery, or surgeons have resorted to hands-on surgical procedures when surgical robots malfunction.
Common patient injuries reportedly include pierced (perforated) organs and tissue, infections, and electrical burns. Some reports suggest that as many as 70 deaths since 2009 may be linked to surgical robots. For example, one Chicago man reportedly died after a surgical robot pierced his intestines during spleen surgery, leading to a fatal infection.
The FDA has recently renewed its focus on Intuitive Surgical and the da Vinci Surgical System. In March 2013, the FDA issued a voluntary request that hospitals and health care workers report adverse events involving surgical robots. This builds upon existing requirements that Intuitive Surgical report adverse events to the FDA.
Further, a May 30, 2013 FDA inspection of Intuitive Surgical's facilities reportedly found a number of problems. These included failing to report updated device usage information to the FDA, failing to report injuries associated with the system to the FDA, and failing to inform the FDA that the da Vinci System was no longer recommended for thyroid removal surgery.
Lawsuits seeking compensation for injured patients have followed. Some have sought compensation for the families of patients who died following robot surgeries. Others have alleged injuries after system malfunctions required surgeons to resort to more invasive procedures. Consumer attorneys have told media outlets that as many as a thousand people may file lawsuits against Intuitive Surgical and doctors.
Because medical professionals control surgical robots, lawsuits alleging patient injuries can involve claims of both product liability and medical malpractice. Product liability lawsuits focus on product defects the cause injuries to occur. Failure to maintain surgical robot systems, system malfunctions, and other technical problems may lead to product liability lawsuits.
Medical malpractice lawsuits, on the other hand, focus on the negligence of medical professionals. Doctors and other medical professionals may be liable for medical malpractice if their treatment fell below the standard of care applied in the industry. For example, a medical malpractice lawsuit may be appropriate if the surgeon received inadequate training before using a da Vinci Surgical Robot, or if the surgeon improperly used a surgical robot.
If you were injured during a da Vinci procedure, you're probably facing painful corrective surgeries and substantial medical bills. A product liability lawsuit can help patients receive compensation for any medical costs, lost wages, and pain and suffering that result from da Vinci complications. Since product liability is a complicated area of the law, it's in your best interests to contact an experienced product liability attorney for assistance.