Known as a breakthrough in surgical technology, the da Vinci Surgical System is a minimally invasive device, which seemed promising to doctors and patients alike. Imagine the benefits of having cardiac, colorectal, general, gynecological, thoracic or urologic surgical procedures performed with only a tiny incision. That could mean minimal blood loss, small scars and a quicker recovery period. Maybe it seemed too good to be true.
Thousands of patients have complained of various complications from the da Vinci Robot system such as lacerations to internal organs, including intestines; burns to internal organs and blood vessels; hemorrhaging; nerve damage; severe bowel injuries; punctured blood vessels and/or uterus; various vaginal injuries and death.
It is believed that so many of the complications and patient deaths were linked to surgical mistakes due to insufficient training or by the machine’s design. There are growing reports that the da Vinci Surgical System is prone to a number of surgical mistakes, possibly linked to the use of its all-metal surgical arms. Experts say that the arms conduct electricity from the robot’s electro-cautery 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.
In some cases, the da Vinci robot tears and burns are not noticed 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.
The da Vinci Surgical System was approved by the FDA in 2000 for use in urological, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiac procedures.
With over 400,000 surgeries performed annually, a significant number of lawsuits have been filed against Intuitive Surgical in U.S. state and federal courts. Sources believe the injuries could result in large settlements in the future.
In December 2013, the U.S. Food and Drug Administration (FDA) issued a Class II recall to Intuitive Surgical Inc. The recall of 1,386 devices involved friction with the instrument arms that can cause them to stall, causing malfunction in the product and potential harm to the patient.
July 2013, prior to the December recall, the FDA recalled approximately 30 machine instruments that it said had not been properly tested at the factory.
In November 2013, the company issued two voluntary recalls of other miscellaneous parts of the da Vinci surgical system.
When the FDA issues a Class II recall, it usually indicates that a device might cause “temporary or medically reversible” health problems, as well as the possibility of serious health issues.
Intuitive Surgical Inc., parent company of the da Vinci Robot, took a $67 million “write down” in product liability costs for its malfunctioning components, the Monopolar Curved Scissors (MCS) and MCS Tips, involving the robot litigation. This in no way means that Intuitive will accept liability or begin settling cases in bulk in the near future.
da Vinci continues to fight claims in the multidistrict litigation, however, sources indicate Intuitive is open to resolving some cases quickly at discounted values in hopes of reducing the number of claims being filed.
Intuitive Surgical Inc. continues to market the da Vinci Robot, which sells for an average price of $1.3 million to $2.25 million, according to a New York Times report. The machines are being used in hospitals throughout most of the U.S.
As a result of the poor surgical training and defective design, 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. If you or a loved one sustained injuries or death following a robot assisted procedure, you should contact an experienced attorney to discuss your options. Feel free to call one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.