Fujifilm has been informed that the subject endoscope was cultured and tested positive for over 100 cfu involving multiple low/moderate microorganisms such as sphingomonas paucimobilis, dermabacter hominis, staphylococcus pettenkoferi and corynebacterium striatum.As the subject unit was being sampled and cultured as part of a postmarket surveillance activity, no patients were involved or exposed to the endoscope.Per study protocol, the endoscope was immediately quarantined after initial sampling, until culturing data were available.Following the positive culture, the endoscope was not clinically reused.The additional sampling and culturing were performed after the second disinfection, and confirmed that no organisms were present.The endoscope was sent back to fujifilm for instrument inspection/evaluation by fujifilm, and no device failure was confirmed.
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