Mounting Incident Reports and Da Vinci Surgery Robot Lawsuits Prompt FDA to Survey Hospitals
Rising adverse event reports, Da Vinci Surgery Robot lawsuits and now a U.S. Food and Drug Administration (FDA)-sponsored survey measuring surgeon training and rates of complication at key hospitals in the U.S. continues to raise questions about the future of this health care technology, Bloomberg.com reports.
According to an article published Mar. 1, 2013, the FDA has reached out to surgeons at top hospitals in the U.S. and asked them to respond to a list of criteria about the Intuitive Surgical Inc.-manufactured device.
The machines, which cost about $1.5 million each, were used in almost 500,000 procedures performed in 2012 and have been at the center of a mounting number of da Vinci Surgery Robot lawsuits. Given that number, doctors were asked their opinions on which surgeries the Da Vinci Surgery Robot is best and least suited for. They were also required to describe the training they received to use them.
The Da Vinci Surgery Robot was approved in 2000 to aid in laparoscopic, urologic, and gynecologic surgery. The surgical tool is also used to perform gall bladder removal, gastric bypass surgery and thyroid cancer procedures.
News of this survey, which was sent to facilities part of a product safety network overseen by the agency, was announced as the number of adverse event reports stemming from the robots continues to rise.
This past January, hedge fund Citron Research reported that approximately 4,600 adverse event reports have been filed over the device. Found in FDA’s MAUDE database, 3,900 of those reports were filed between 2007 and 2012.
Side Effects Claimed in Da Vinci Surgery Robot Lawsuits
Patients who have already filed Da Vinci Surgery Robot lawsuits have allegedly experienced the following side effects:
- Surgical burns and tears to vital organs
- Surgical burns and tears to arteries and other blood vessels
- Cut ureters
- Bowel Injuries
- Excessive bleeding
What the FDA is trying to figure out is whether the rising number of adverse event reports stemming from use of the robot is “a true reflection of problems,” or caused by other issues, according to a spokeswoman for the agency, Bloomberg.com reported.
She added, “It is difficult to know why the reports have increased.”
Considering a Da Vinci Surgery Robot Lawsuit? Call Us Today.
If you or someone you love suffered surgical burns, organ damage or other serious injuries after undergoing a Da Vinci Surgery Robot procedure, you may be eligible to file a Da Vinci Surgery Robot lawsuit. Bernstein Liebhard LLP is currently offering free legal consultations to victims of alleged device failure. To learn more about how to file a Da Vinci Surgery Robot lawsuit, please give our lawyers a call today, at 1-877-779-1414.