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The da Vinci Surgical System has been linked to a number of complications and patient deaths, which may have been caused by surgical mistakes from insufficient training or by the machine’s design.
STATUS OF DA VINCI SURGICAL SYSTEM LAWSUITS: Potential claims have been pursued by individuals who have been injured or lost loved ones due to problems following robotic surgery with the Da Vinci Surgical System. As of May 2015, most claims have settled or lawyers are no longer accepting cases for new injuries.
MANUFACTURER: Intuitive Surgical, Inc.
OVERVIEW: The da Vinci Surgical System was approved by the FDA in 2000 for use in urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.
The surgical robot has four arms, three for holding surgical instruments including scalpels and electrocautery instruments, and a fourth with an endoscopic camera. It is controlled by a surgeon looking through an imaging device at a 3-D image of the surgical area. The surgeon controls the robot with foot pedals and hand controllers.
According to the company’s website, the robot has been used in procedures to treat a number of cancers, including bladder cancer, colorectal cancer, gynecologic cancer, kidney cancer, prostate, cancer, and throat cancer. They are also marketing the device for use in procedures for coronary artery disease, endometriosis, heavy uterine bleeding, kidney disorders, obesity, and other problems that can be corrected with surgery. The company describes the use of the da Vinci as a “new category of minimally invasive surgery.”
DA VINCI SURGICAL MISTAKES: There are growing reports that the da Vinci Surgical System is prone to a number of surgical mistakes, potentially linked to the use of its all-metal surgical arms. Some say that the arms conduct electricity from the robot’s electrocautery instruments, which can then arc and burn arteries and vital organs in unintended locations. The robot could also tear internal organs by accident, some say.
Often, the da Vinci robot tears and burns are not apparent during or immediately after surgery, which could result in delayed treatment for internal injuries and death. Tears and burns to blood vessels, intestines and reproductive organs are the most commonly reported complications.
There are also concerns that surgeons have not been properly trained to use the device. It employs hand controls and foot pedals which the surgeon must use to guide the multi-armed robot in precision operations while looking through eye holes at a 3-D image created by stereo cameras. Some experts are concerned that the videogame-like interface is so far removed from normal surgical operations that it requires far more intensive and specialized training than Intuitive Surgery, Inc. has provided.
DA VINCI ROBOT COMPLICATIONS: The complications and reports of injuries and deaths has led some experts to question whether the benefits of the device are outweighed by the risks. There are also concerns that da Vinci surgical procedures are more expensive than traditional surgery with no extra benefits. The machine costs $2 million plus heavy annual maintenance costs.
A study published in January 2012 in the Journal of Clinical Oncology found that women treated for endometrial cancer had about the same complication rates through traditional laparoscopy as they did following a da Vinci surgery. However, using the da Vinci cost about $1,300 more.
As a result of a defective design and poor surgical training, patients may have suffered injuries or death due to a robotic surgical procedure that is more expensive and may have no benefit over traditional surgery. A number of individuals throughout the United States are now pursuing compensation through a da Vinci Surgical System lawsuit as a result of the manufacturer’s failure to properly design and test the device and the skills needed to operate it.