Medical device manufacturer, Olympus Medical Systems Corporation, has issued a medical device safety alert concerning its Olympus CHF-CB30S Choledochoscopes [Serial Number: All].
The manufacturer informs users of a removal action of all OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30S (CHF-CB30S) from the market. This removal action is being taken after the manufacturer conducted a retrospective review of modifications to the CHF-CB30S.
As part of that review, the manufacturer conducted a post market risk assessment of the CHF-CB30S, which showed that this device has been associated with breakage of the insertion portion and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures. One of these complaints was associated with a serious adverse event, wherein surgery was required to remove rubber fragments which remained in the bile duct.
According to the manufacturer, affected users are instructed to cease further use of any CHF-CB30S device, remove it from inventory and quarantine it until it is sent back to the manufacturer. Product removal 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 2 September 2020