Have You Or a Loved One Suffered Complications Following an Operation Involving the da Vinci Robotic Surgical System?
The medical device lawyers of the Stampfle Law Firm are opening their doors to patients who that may have been injured by the da Vinci Robotic Surgical System from Intuitive Surgical. A recent surge in the number of adverse effects reported in association with the device has prompted the Food and Drug Administration to take a look at the item’s safety and efficacy, and we want to hear from patients who may have suffered an injury during a procedure involving the da Vinci
The rise in the number of incidents comes with an attendant rise in popularity. An investigation by ABC News showed that 367,000 procedures involving the da Vinci were carried out in 2012, a jump of 253,000 from four years prior. The devices are prevalent in hospitals across the country, with an estimated 1,400 facilities having at least one da Vinci on hand, meaning that about 25% of American hospitals use the device.
The intensive marketing and promotion of the system belies a lack of research into whether or not the devices are anymore effective or safe than a procedure carried out by human hands. The da Vinci allows a surgeon to manipulate the device from a master control console, with the thought being that the robot affords exacting control on surgical instruments and maneuvers and even reduces the chance that a severe bleeding event will take place.
New research and the filing of incident reports cast the devices in a new light. Since the beginning of 2012, 500 reports have been filed detailing instances of complications, although it should be noted that Intuitive Surgical was responsible for filling out many of those and some are duplicates. It is also believed that many incidents associated with the device have not been reported.
Just what kinds of potentially hazardous situations have occurred? One man allegedly suffered a colon perforation in the midst of a prostate surgery, while another person had their tissue grabbed by the da Vinci. Doctors reported that the robotic arm refused to let go, requiring overseers to initiate a shutdown of the device. One woman reportedly suffered a blow to the face by one of the robotic arms.
Some incidents have had serious consequences to the patients involved. Five fatalities can be found within the aforementioned reports from 2012 onward, including one in which a woman died after the robotic arm cut a blood vessel.
The da Vinci has been approved for a number of procedures, including gynecologic, thoracoscopic, and gallbladder surgery, as well as a number of other soft tissue operations.
The training being provided by the manufacturer to surgeons is not nearly as extensive as the training Intuitive Surgical indicated it would provide when market approval was sought from the FDA. Although the company is providing some training on the robot, it is suggested that the training is designed to give the surgeon the belief that he or she is adequately prepared to begin performing surgeries with the device when much more extensive training should be provided.
This suggests that some surgeons may be jumping the gun in terms of their readiness to safely operate the da Vinci. In 2010, the New England Journal of Medicine featured an article that suggested 150 or so operations have to be carried out before a surgeon is fully capable of operating the device.
Lawsuits have already been filed, and many of them focus on the training of the surgeon involved in the injurious operation. Recently, a jury awarded $7.5 million to the family of a Chicago man who died following an operation involving the da Vinci. The lawsuit claimed that a lack of training led the da Vinci robot to puncture the man’s intestines, at which point a fatal infection developed. It was argued that the nature of the surgery did not dictate the usage of the da Vinci and that a doctor involved in the procedure had never before used a robot in an operation.
Patients should make themselves aware of some of the typical injuries faced by those who have had a da Vinci operation go awry:
If you have experienced these or any other injury in association with an operation involving the da Vinci Robotic Surgical System, the Stampfle Law Firm wants to hear from you. Whether your injury stems from a lack of surgeon training or a defect in the device itself, you may be entitled to compensation. The same applies to if you’ve lost a loved one because of such an operation.
Our defective medical device lawyers are waiting to hear from you, so call today to take advantage of our free consultation service. We can help you get a better handle on the situation so that you know your options moving forward.