GREY:TSTIF - Post by User
Post by
lematou22on Mar 19, 2016 2:07pm
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Post# 24679137
Some More Fun for Olympus
Some More Fun for OlympusIt might seem that for the very short term Olympus has burried it"s regulatory problems from the TJF-Q180V.
It is only a short respite before it gets into further problems with other models of it's scopes designed to be used in gastroenterology procedures, where the duodenoscopes are only a subset.
For a peak, link to the Maude System of the FDA where hospitals and others report suspect incidents with medical devices (link below). In the Brand Name field, type in the word "EVIS EXERA" which is the generic name for a whole set of scopes y Olympus. and ask for a listing of incidents covering a period of a few months. 02/ 11/2015 to 02/29/2016 for example. And then have fun.
You'll find some cases that seem pretty inocuous, but also many other situations of patients having been infected with CRE (with daths in sme instances) and also other cases that specifically refer to ERCV procedures again with ensuing deaths of patients.
I, for one, have especially noted how hospitals hang on to the scopes instead of turning them over to Olympus for further analysis. Inmy noteook, it is written legal claims in preparation.
Enjoy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm