Medical device manufacturer, Olympus has issued a medical device safety alert concerning its Endocuff Vision [Model number: ARV110, ARV120, ARV130, ARV140; Lot number: 60496 to 70914]. Product details are as follows:
Owing to an irregularity in the packaging process of the above listed products, it has been identified that there is a potential packaging seal defect which may allow a breach of the package's sterile barrier. This issue can be detected with the naked eye prior to use once the lid has been removed from the plastic package.
A breach of the package's sterile barrier might lead to patient infection (example includes a gap in the seal between the lid and the plastic package). According to the manufacturer, it has not received any complaints or reports of injuries, infections or required medical intervention as a result of this issue. If users see this packaging anomaly or any other damage to the packaging, they should not use the product and report to their local representative. Meanwhile, users can continue to use the device in accordance with the Instructions for Use.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 17 June 2021