It is being reported that Olympus sold its TJF-Q180V duodenoscope after making changes to the design, but without FDA approval. This design change created a device that was difficult to clean and no safer than the original design. The duodenoscope has now been implicated in the outbreak of a deadly drug-resistant superbug (CRE or carbapenem-resistant Enterobacteriaceae) that has killed at least 2 patients and sickened at least 7 others at a Los Angeles hospital. The FDA has confirmed that Olympus did not seek the required 510(k) clearance for the modification it made to the original design that had been cleared by the FDA.
See: http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission - See more at: http://www.dcrashlaw.com/blog/18858/#sthash.4rUhxY5t.dpuf