Medical device manufacturer, Olympus, has issued a medical device safety notice concerning its Olympus Endoscopic Ultrasound Endoscopes [All serial numbers of these Models: GF-UE260-AL5, GF-UCT260, GF-UE160-AL5, GF-UCT180, GF-UE190, GF-UE290, GF-UC140P-AL5, GF-UCT140-AL5, GF-UC240P-AL5, GF-UCT240-AL5, GF-UM20, GF-UM130, GF-UMQ130, GF-UMP230, CF-UMQ230, GF-UM240, GF-UMQ240, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5, GF-UM2000, GF-UC2000P-OL5, GF-UCT2000-OL5 are affected]
According to the local supplier, only the following affected Models are distributed in Hong Kong: GF-UCT240-AL5, GF-UCT260, GF-UE260-AL5, GF-UE290, GF-UM2000, GF-UCT180, GF-UM160, GF-UM240, CF-UMQ230 & GF-UMQ240.
The manufacturer is issuing validated, revised instructions for use with the products after an investigation indicated a potential risk of infection due to residual blood and foreign matter in the air/water channel of the Convex Ultrasound Endoscopes (GF-UCT260, GF- UCT240-AL5, GF-UCT140-AL5 and GF-UC240P-AL5). Since the products have a similar structure to the Convex Ultrasound Endoscopes, in order to mitigate the risk of infection, the manufacturer has updated the instructions for use (IFU) for the affected products to add an inspection step before reprocessing to help determine if there is complete blockage of the air/water channel. If air/water channel blockage is identified, the user should no longer use the product and contact the manufacturer to make arrangements to repair the product.
Users should refer to the Addendums of the manufacturer's notice for details on the required actions to take to determine if there is a full blockage of the air/water channel. The new inspection steps should be implemented as soon as possible:
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 6 November 2020