Da Vinci® Surgical Robotic Systems Subject of "Urgent Medical Device Recall"
The potential risks and relative benefits of robotic surgery have been the target of widespread debate in recent years. The controversy regarding the merits and safety of using Intuitive Surgical Inc.'s surgical robot system is expected to intensify following two separate safety warnings issued during the last month including what has been referred to as an "urgent medical device recall."
Intuitive Surgical Inc. issued a warning on November 11 indicating that the system's robotic arms can stall during surgical procedures because of friction which can interrupt the movement of the robotic arm. According to a Wall St. Cheat Sheet online report, the company issued an "urgent medical device recall" covering 1,386 systems currently being used in hospitals and other surgical centers throughout the U.S. and other countries.
The Food and Drug Administration (FDA) indicated in a Dec. 3 posting on its website that the friction can cause the arm to snag and lurch forward when surgeons attempt to push past the friction. According to the FDA report, the number of adverse effects reported that involve the medical device manufacturer's surgical robot device have increased by more than a hundred percent this year based on reports through the early part of November. These adverse effects include system malfunctions, injuries and fatalities. The FDA has classified the issue as a Class II recall, which means that the agency believes that the device could cause "temporary or medically reversible" health problems or a small possibility of serious injuries or medical complications according to the Wall Street Journal report
This warning regarding Intuitive Surgical's robotic surgery device is the second warning issued regarding the company's robotic surgical systems during the last month according to the Wall St. Cheat Sheet website. The FDA issued a report last month that raised questions regarding the safety of the medical device, aggressive marketing tactics, and insufficient training procedures for surgeons using the surgical technology.
While the FDA has not required that Intuitive Surgical's da Vinci® surgical robot system be removed from the market, the company is informing surgeons and other medical staff about the issue so that the devices can be inspected for potential replacement or repair. The warning regarding the risk of stalls during surgery was issued based on three distinct reports involving the problem during surgical procedures. The Wall St. Cheat Sheet report indicated that two of the reports involved apparent friction while the third resulted in an imprecise incision. Approximately fifty lawsuits related to injuries and complications allegedly caused by the da Vinci® surgical robot system have been filed against Intuitive Surgical according to the report.
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If you or someone close to you suffers a serious injury or medical complication while undergoing robotic surgery, our Georgia personal injury attorneys at Montlick and Associates have been representing injury victims for over thirty years throughout all of Georgia and the Southeast, including all smaller cities and rural areas in the state.
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