Category: Medical Device Reports (MDRs)

A ‘Trickle-Down Effect’: The Potential Impact of the FDA’s Warning About Endoscope Safety on Automated Endoscope Reprocessors

August 19, 2015 — Late last week the FDA “warned” FujiFilm, Olympus and Pentax — the manufacturers of virtually every gastrointestinal endoscope used in the U.S. — for failing to…

FDA Warns Three Endoscope Manufacturers for Safety Violations Following Deadly ‘Superbug’ Outbreaks

August 18, 2015 — The FDA has “warned” the three manufacturers of medical endoscopes used in the U.S. for failing to comply with federally mandated regulations. Last week, the FDA…

A 2015 ‘Superbug’ Outbreak in North Carolina: Were Contaminated Duodenoscopes to Blame?

June 15, 2015 — The Mountain Xpress, a local newspaper in Asheville (NC), reported earlier this week that two patients died in February at a hospital in North Carolina “from…