Columbus, OH (PRWEB) September 09, 2013
The Da Vinci robotic surgery lawsuit lawyers at Wright & Schulte LLC, an experienced defective medical device law firm, are disturbed by the findings of a newly-published study which indicates that complications associated with the Da Vinci Surgical System could be vastly underreported. The study, which appears in the Journal for Healthcare Quality, found that just 245 robotic surgery complications were reported to the U.S. Food & Drug Administration (FDA) between 2000 and 2010. During the same time period, the Da Vinci robot was used in at least 1 million procedures. Considering its widespread use, the research team asserted that the number of complications reported to the FDA was extremely low. A search of federal court records in Da Vinci robotic surgery lawsuit and media reports also revealed five instances of Da Vinci robotic surgery complications that were never reported to the FDA, and three cases that were misreported.
hopkins_study_suggests, Johns Hopkins Medicine, September 3, 2013]
"Doctors and patients can't properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent,” Martin A. Makary, M.D., M.P.H., lead author of the study, said in a statement issued by Johns Hopkins University.
The release of the Johns Hopkins study comes just weeks after Intuitive Surgical, Inc., the manufacturer of the Da Vinci robot, acknowledged that it had been named in at least 33 Da Vinci robot lawsuits, [sec.gov/Archives/edgar/data/1035267
/000119312513297410/d551118d10q.htm; SEC, July 22, 2013] which allege the use of the device resulted in serious, and in some cases, fatal injuries. Wright & Schulte LLC is now offering free personal injury lawsuit consultations to victims of alleged Da Vinci surgical robot complications, including those who suffered:
For more information on filing a Da Vinci robot lawsuit, or to arrange for a free legal consultation, please visit yourlegalhelp.com.
[sec.gov/Archives/edgar/data/1035267/000119312513297410/d551118d10q.htm; SEC, July 22, 2013]
The Da Vinci Surgical System was launched by Intuitive Surgical in 2000, and is the only robotic surgery platform approved by the FDA for use in soft tissue procedures. According to a recent Bloomberg News report, the device has been associated with a growing number of adverse event reports, which prompted the FDA to launch a survey of doctors who use the robot earlier this year. Among other things, the agency is seeking information on the types of Da Vinci robot complications physicians may have observed.
[bloomberg.com/news/2013-03-21/intuitive-robosurgery-training-seen-lacking-in-lawsuits.html, Bloomberg, March 21, 2013]
According to Wright & Schulte LLC, the newly-published Johns Hopkins study is just the most recent development to raise questions about the safety of the Da Vinci robot. In May, Intuitive Surgical warned its customers about an issue with its EndoWrist Monopolar Curved Scissors that could cause surgical burns in patients. In July, the company was sent an FDA Warning Letter after an inspection of its headquarters turned up several issues, including problems with the way it reported Da Vinci complications to the agency. That same month, Intuitive Surgical announced a recall for some Da Vinci instruments that may not have been properly tested at the factory.
[fm.cnbc.com/applications/cnbc.com/resources/editorialfiles/2013/05/10/UrgentDaVinci.pdf, Intuitive Surgical, May 8, 2013]
[fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm363260.htm, FDA, July 16, 2013]
[bloomberg.com/news/2013-07-12/intuitive-surgical-may-not-have-tested-devices-properly.html, Bloomberg, July 12, 2013]
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795. You can also visit and like our Robotic Surgery News on Facebook for all the latest news..
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