See this really interesting interview with Olympus....

Started 2 months ago | Discussions thread
JakeJY Senior Member • Posts: 3,638
Re: Ok 2014.

Raist3d wrote:

JakeJY wrote:

Raist3d wrote:

https://www.massdevice.com/olympus-fined-85-million-in-dirty-duodenoscope-case-former-exec-faces-prison/

that for purposely hiding data about infection with their endoscopes

That was less than a year ago what’s really sad is all the good people at a company that work hrs suffering by the management unethical choices here

but looks like Olympus is still doing things

Again that is for violations that happened in 2012 and 2013 (when they were in the middle of the scandal). You need to actually read the article, not just look at the date posted or the ruling date. Cases can take a long time to process.

From the article, 2014.

"Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes."

Still quite something. You would think after the original scandal, this wouldn't happen. In this case is worse as it is medical.

"Olympus admitted that it failed to file adverse event reports with the FDA in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V)"

Those up to October 2014 were only deemed misbranded because they failed to file the MDRs in 2012 and 2013. I could totally see that happening while they were still restructuring from the scandal.

At any rate, even 2014 is substantially older than what was originally suggested.

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