The device has not returned for investigation yet.According to the physical appearance of the device on the provided pictures, most likely, the device (especially the outer cannula) seems not to be cleaned as instructed in the ifu.A detaching of a tube from the neck plate is a long-term process and will not happen all at once.Several warnings in the enclosed ifu state that the device may not be used any longer, if the material of the device appears to be discoloured or damaged.The removing of the separated cannula is comparable to a normal exchange of the device by the patient when its replaced by a new one.Important notice: due to problems with the submission via esg, we have already sent this report on friday, february 10, 2017 manually via ups express mail.In the meantime the problems with the electronic submission could be resolved, so that we also submit our report of friday, february 10, 2017 hereby electronically.Not returned to manufacturer.
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