More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018. The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body. When the FDA initially announced the meeting in March, it acknowledged in a letter to doctors that “many more device malfunction reports” were reported to the agency than it

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From https://jamesjohnson10.blogspot.com/2019/05/more-than-half-of-surgical-stapler.html

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https://jamesjohnson10.wordpress.com/2019/05/31/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/