Medical device manufacturer, Aesculap AG, has issued a medical device safety alert concerning its Doyen-Collin Mouth Gag 120mm [OM040R; Production period from February 2016 to October 2017]. An affected product OM040R can be clearly identified by two options:
The manufacturer received knowledge about the possibility that the plastic sleeves of a DOYEN-COLLIN MOUTH GAG 120MM - OM040R could stick together after reprocessing.
According to the manufacturer, the used plastic sleeves of the instrument do not meet the valid specification. Instead of the specified material silicone, the material PVC was used for the manufacturing of the sleeves. This could render affected instruments unusable after reprocessing. The results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product.
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 14 February 2018