Medical device manufacturer, Olympus Medical Systems Corporation, has issued a medical device safety alert concerning its Olympus BF-Q180 Video Bronchoscope [Serial Number: All].
The manufacturer informs users of a removal action of all EVIS EXERA II BF-Q180 Video Bronchoscopes (BF-Q180) from the market. This removal action is being taken after the manufacturer conducted a post market risk assessment of the BF-Q180, including adverse events review, which showed that the BF-Q180 is associated with a higher rate of patient infections than other comparable Olympus bronchoscopes. While this rate of infection is low (less than 0.01%), and patient infection rates depend on a number of factors, out of an abundance of caution and to minimize to the fullest extent possible the risk of infection, the manufacturer has begun a worldwide transition of the BF-Q180 to newer bronchoscope models.
According to the manufacturer, in the meantime, affected users may continue to use their BF-Q180 according to the steps described in its Operation Manual and Reprocessing Manual and in alignment with their regional rules related to hygiene monitoring. Any endoscope showing any irregularity should not be used but returned to the manufacturer.
Product exchange/replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 September 2020