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FDA investigating da Vinci surgical robots for defects

Robotic surgical systems may be unsafe for patients, with some robotic surgeries causing serious injuries and even death in surgical patients. The dangers of these surgical devices have become more apparent, and federal regulators have started to investigate their use in U.S. hospitals.

One robotic surgical system, the da Vinci surgical robotic device, has come under intense scrutiny after reports of injuries and complications in patients who had robotic surgery with this specific robot. The Food and Drug Administration said that they have received 500 reports of defective da Vinci surgical robots, forcing the FDA to investigate the devices.

The FDA is currently reviewing the da Vinci robotic devices and are surveying surgeons for complications associated with the da Vinci devices. The da Vinci robots are the only devices approved by the FDA for soft tissue procedures including prostate removal, heart repair, hysterectomy and organ transplants. Since the da Vinci robots are the only approved robotic surgical devices for many soft tissue procedures, many surgical patients are at risk for suffering a surgical error or complication due to the potentially defective medical product.

Surgical patients around the U.S. have already filed lawsuits against the manufacturer of the da Vinci robots, alleging that they have caused internal injuries, tears, burns and other injuries that cause chronic pain, disability and even death. Many of the lawsuits claim that the surgical robot has design flaws that make it difficult for surgeons to use the device properly.

The claims that the da Vinci surgical robots are defective and the lawsuits that have been filed against the device's manufacturer is an example of the legal action patients can take against companies that produce and sell dangerous or defective medical devices.

Source: News Inferno, "Hospitals May Be Underreporting da Vinci Robotic Surgical System Incidents," Cynthia A. Diaz-Shephard, May 13, 2013

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