Da Vinci Robotic Surgery Lawsuits May Prompt Heightened Hospital Training
Robotic surgery has been marketed to patients as a safer way to go under-the-knife than more conventional surgeries. However, the rising number of deaths and serious injuries linked to the robotic systems is not only fueling patient lawsuits, but putting the pressure on hospitals to better train doctors in the use of these devices.
The “da Vinci” Surgical System is a sophisticated robotic platform designed to allow surgeons to make fewer, smaller, and more precise incisions when performing surgery on patients through the use of its magnified 3D high-definition camera and miniature “jointed-wrist” instruments. Despite it being known as “robotic” surgery, the da Vinci system does not operate on its own, but relies on a human operator. According to the da Vinci surgery website, the system “enables your surgeon to operate with enhanced vision, precision, dexterity and control” while leaving the surgeon “100% in control.”
Approved by the FDA in 2000, more than 1.5 million adult and pediatric surgeries have been performed using the da Vinci system for common laparoscopic procedures including gynecologic surgeries, cardiac heart valve repairs, prostate removals and others. However, following reports of patient injuries the FDA began investigating problems with the device in early 2013. The FDA issued a class II recall of 30 da Vinci devices after it found its testing devices weren’t working properly. This year alone, the FDA has reportedly received 3,687 adverse event reports.
While the FDA’s investigation into design problems continues, the FDA’s recent surgeon survey* suggests that inconsistent surgeon training, or lack thereof, may be another problem in causing patient injuries. Jeff Berkley, chief executive of Mimic Technologies Inc., which makes robotic surgery simulators for training purposes, told Bloomberg “[t]raining for robotics has been the wild, wild west for a long time” and that hospitals and doctors realize “they have to get their act together and start focusing on training.”
The doctors surveyed by the FDA reported a special learning curve in using the device. Since the doctors do not directly touch the surgical instruments when using the robotics system, they must rely solely on vision, judgment and training. Despite this learning curve, the manufacture does not require specific training for doctors – the manufacturer merely “recommends” training. According to the survey, training to date has been varied, to say the least, ranging from a few hours of online training, to watching videos, to actual training on a simulator or in cadaver labs. However, the increase safety concerns and increase of lawsuits over patient injuries is expected to pressure hospitals to require heightened training programs before surgeons utilize robotic surgery on patients.
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If you, or a loved one, have experienced problems that may be related to a robotic surgery, contact the experienced attorneys at Audet and Partners, LLP for a free evaluation of your legal options. Call us at (800) 965-1461 or complete and submit our confidential online inquiry form on the right side of this page.