FDA: Manufacturer never had permission to sell device connected to superbug deathsCNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration. Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs. "Why didn't we notice it? I don't know," Riley said.
Olympus is run by total fucking buffoons. This is no surprise! Just like everything else at Olympus, It's all run halfass! Upper management are asleep at the wheel, Per usual. It's almost funny how fucking dumb they are!
Selling an un approved device and infecting peoe with a superbug virus nobody knows how many are Infected .. Lawsuits are on the way.. What doctor will trust you guys ever again? If I'm running an endo center im telling my rep to come in and collect every scope in the building and get the hell out and never comeback.. And oh yea you'll be hearing from our lawyers
I believe you are right. There is only one place this money for lawsuits and settlements to come from and that is the sales force commissions. Most accounts ask for a 510k before you bring in anything for trial so I'm curious what the reps from OLY gave them? If they gave them an inaccurate document it's complete fraud and deceitful. I'm sure someone in Center Valley is using a shredder as we speak. This is going to impact all aspects of their business.
Piece of shit corrupt organization Literally filled to the rim with Douchebag management! I hope Olympus goes down in a ball of flames!!!
I predict this will be bad...very bad for Olympus GI. This may be the tipping point that turns market share south. Will be interesting to watch how hospitals affected spin this off to Oly. Interesting
http://kdal610.com/news/articles/2015/mar/05/washington-state-woman-files-wrongful-death-lawsuit-over-superbug-infection/
