Robotic technology has revolutionized every single aspect of our lives especially within the healthcare industry. Every year thousands of people go through robot-assisted surgery for a variety of procedures such as for prostate operations, hysterectomies, joint replacements, delicate neurosurgical procedures, cardiac surgeries, kidney surgeries, colorectal and ear, nose and throat surgeries.
Many medical professionals and hospitals believe that robotic surgery is a cost effective and more efficient way to perform complex surgeries because it is less invasive, faster, more precise, more flexible and generally more comfortable for the patient, as well as because they provide improved diagnostic abilities. This has made robotic surgery quite popular. Intuitive Surgical, the maker of da Vinci robotic surgery devices, is credited with producing the most popular machines.
Although many hospitals across the country have embraced this technology, emerging evidence seems to suggest that robot-assisted surgery carries new risks.
The Food and Drug Administration (FDA) has disclosed that the device maker broke various procedures since it warned clients of the problems linked to da Vinci surgical system without first notifying regulators. The FDA claims that Intuitive received 134 complaints and filed 83 medical device reports between January 2010 and December 2011 all related to damaged tip covers that have resulted in patient injury after the surgery.
In October 2011, Intuitive sent letters to customers with recommendations regarding the proper use of tip covers as well as correct generators that should be used in its EndoWrist Monopolar Scissors. The corrections were in response to complaints about “arcing through damaged tips which caused the injuries to patients,” according to the FDA. Arcing happens when electrical currents are conducted to the patient’s body during the operation.
In 2013, Intuitive Surgical Inc. issued an urgent warning to all the hospitals using their da Vinci systems, saying that “a component in one of its robot systems could be putting patients at risk for burn injuries”. The company went on to say that some versions of their Hot Shears system “have small cracks which could create pathways for an electrosurgical charge”. Unfortunately, these cracks are not visible to the naked eye. Despite the malfunction, the company still hasn’t removed the system from hospitals.
Dr Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore, argues that safety of robotic surgery should become an integral part of the entire pro / con debate and adds that “patients need to know the truth about robotic surgery. The Achilles-heel feature of the robot is its lack of tactile feedback, which can spur inadvertent injuries if added caution is not taken.
In the period between January 1, 2000 and August 1, 2012, the FDA received 245 reports referring to adverse effects of the da Vinci robot-assisted surgery. Additionally, Dr Makary and his colleagues found another 5 cases that were never reported to the FDA and 3 that were quite problematic. Dr Makary adds: “We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there. The number of reported cases seems very low, given the discussion of these events in the surgical community.” His and his team’s findings were recorded in a September 2013 study published in the Journal for Healthcare Quality. Dr Makary also states that in one study, anonymously surveying surgeons, “56.8% of them reported irrecoverable operative malfunction while using the da Vinci system”.
In addition to the reports from the FDA, instances of adverse effects and complications from robotic surgery are unfortunately on the rise. The doctors at Rush University Medical Center, the Massachusetts Institute of Technology and the University of Illinois have drafted reports in which they say that the number of injuries and deaths from robotic surgery have been constantly on the up with over 50 reports of injury and death per 100,000 procedures last year alone. For comparison, 13 people were injured or died from robot-assisted surgeries in 2004.
Some patients who have gone through procedures using the da Vinci equipment have reported experiencing various complications. One particular patient suffered bleeding into her pelvis from an injury to a major artery in the course of a robot-assisted hysterectomy. The patient died 13 days after the surgery.
Although Intuitive has tried to control the problem by replacing the tip covers, the FDA robotic surgery warning regarding the device still exists. This is because “the manufacturer’s new tip cover does not seem to be completely effective in stopping the electrical sparks which have the potential to burn tissue.
If you are one of the patients injured by the da Vinci machine or know someone who has developed complications from this procedure contact the law firm, Gurfein Douglas, the lawyers with an edge.