News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

FDA: Intuitive Surgical, Inc. (ISRG) Failed to Report Warning


6/26/2013 8:28:39 AM

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

The Food and Drug Administration says Intuitive Surgical, which makes the da Vinci surgical robot, broke procedures when it warned customers about problems with the robot without first alerting regulators. In what is known as a "483" letter following a recent inspection the FDA said that between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to "tip cover issues." According to the FDA, in October 2011 Intuitive sent customers a letter with "suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments."

Help employers find you! Check out all the jobs and post your resume.

Read at CNBC
Read at RTT News
Read at Barron's Online

comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES