Medical device manufacturer, Penlon, has issued a medical device safety alert concerning its Crystal Metal Disposable Laryngoscope Blade - MAC 3 [Catalogue Number: 50674, Lot Number: 002304, 002305].
During the course of global post market surveillance activities, two cases of broken light-guides relating to a single batch of the affected products have been reported to the manufacturer. There have been no instances of patient harm or deterioration in health.
According to the manufacturer, under the most severe of circumstances, if the light-guide has had some trauma or shock to it, it may break off and a small piece may obstruct or damage the patient airway. Identified failure rate is estimated at 0.09%.
All users are advised to identify, quarantine and return the affected products to the manufacturer. The manufacturer will address any supplier concerns over durability of light-guide and improve the manufacturing process with additional testing and inspection regime.
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 11 February 2019