Medical device manufacturer, Olympus, has issued a medical device safety alert concerning its EndoTherapy devices [Model: B-V232P-A, SD-210U-10, SD-210U-15, SD-210U-25, SD-230U-20, SD-240U-25, SD-400U-10, SD-400U-15, B5-2C, B7-2C, K-201, K-202, K-204, KD-611L, KD-612U, KD-655L, KD-655U, NA-401D-1321, NA-411D-1321, NA-411D-1521, NM-400Y-0423, NM-600L-0421, NM-600L-0423, NM-610L-0423, NM-610U-0423, CC-220DR, MAJ-244, NA-201SX-4022, NA-201SX-4021; Multiple Lot Numbers].
According to the manufacturer, due to an anomaly in the packaging process of the devices with the associated lot numbers, it is possible that the sterility of these products is compromised due to a defective seal, which may allow a breach of the package's sterile barrier. This breach may be difficult to detect with the naked eye.
The manufacturer has not received any complaints of injury associated with defective package seals related to this issue. However, it is possible that the use of non-sterile products may introduce microbes and potentially increase the risk of postoperative infection.
Affected users should immediately cease any further use of any affected product they have, remove it from their inventory and quarantine it until it is shipped back to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 17 December 2020