Field Safety Notice Olympus Single Use Electrosurgical Snare SD-400 (ICN 3122)

NHSSC: 77

Alert:

• Olympus has issued a Field Safety Notice regarding specific lots of SD-400U-10 and SD-400U-15 Single Use Electrosurgical Snares.
• Olympus discovered holes in a small number of device pouches.
• Any SD-400 Snare package with a hole cannot be considered sterile.
• If the device packaging has holes and the affected device is used on a patient, there is a potential risk of exposure to a contaminated, non-sterile device, which could lead to infection.

Products Affected:

• The affected products are available from NHS Supply Chain’s eDirect route:

• Please see Attachment 1, page 3, of the Field Safety Notice for detail of affected lots.
• The supplier is unable to fulfil future orders with unaffected stock and is expected to resume supply towards the end of November 2025.
• The affected products will be suspended from the catalogue and unavailable to order.
• There are currently no indirect alternatives identified at this time, however there may be comparable products available.
• Please review the catalogue and consult your own clinical experts to ensure suitability.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Contact the supplier at to arrange collection of affected products by completing the Reply Form, found page 4 of the notice, and return to ra@olympus.co.uk.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and Lot numbers you are returning to the supplier to enable us to manage your credit where appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.