Medical device manufacturer, Richard Wolf GmbH, has issued a medical device safety alert concerning its TEXAS Bronchoscope Tube [Product numbers: 825200641, 825200841, 825200842, 825201041, 825201241, 825201441, 825210830, 825211230, and 825211430].
The manufacturer became aware of a potential deficiency of its TEXAS Bronchoscope Tube product. Non-functionally relevant bonding points / cemented areas of the affected products may come loose and therefore lead to an extension of the operating time.
Generally the affected user discovers such separations of fibers of glue during the visible and the function inspection. They are advised to check their stock and return the affected products to the manufacturer for device correction.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 21 September 2018