Field Safety Notice Olympus Thunderbeat Jaw Thunderbeat Probe Fracture and Tissue Pad Detachment (ICN 3209)

• Olympus has updated their Field Safety Notice QIL FY26-EMEA-17-FY25-009-A to amend the Unique Device Identification (UDI) on page one for two products listed in the Material ID column:
  • EGTB-0545FCS
  • EGTB-0535FCS.
• Please see the attached updated Field Safety Notice for details. There are no other changes.

NHSSC: 91

Alert:

• Olympus has issued an urgent Field Safety Notice dated 8 January 2026, which replaces and supersedes the previous Field Safety Notice issued December 2024 on ICN 2810.
• See our Useful Links section to view ICN 2810.
• Since the release of the advisory Field Safety Notice, Olympus has continued to receive reports of:
  • probe tip damage or breakage – during use
  • tissue pad damage or detachment from the instruments.
• A broken probe tip or a damaged tissue pad may lead to various patient harms. Of these harms, the most common harm is a foreign body in the patient due to a probe tip and/or tissue pad that becomes damaged and breaks off the device during use.
• As a result, Olympia has issued a Product Removal action for these devices.
• In addition, Olympus has identified additional THUNDERBEAT™ hand instrument models which are impacted due to similar probe design, these models are also being removed from the market, please refer to the table in the field safety notice for the full list of impacted devices.

Products Affected:

• Three of the products affected have been supplied on the eDirect service by NHS Supply Chain:

• Please note this product withdrawal is not lot specific and affects all devices issued prior to December 2025.
• Please refer to ICN 3171 for the latest supply disruption situation on these products.
• ICN 3171 will be updated as soon as any further information on anticipated recovery dates and alternatives becomes available.
• See our Useful Links section to view ICN 3171.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Examine your inventory for affected Thunderbeat hand instrument models as listed on page 1 of the Field Safety Notice.
• Immediately cease use of all affected devices and quarantine the products.
• Complete the Reply Form, page 5 of the notice, whether you have affected product or not and return by email to Olympus: ra@olympus.co.uk
• Olympus will arrange collection of the affected products in your possession.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including NPC, lot number, and quantity, this will enable us to raise the appropriate credit on your behalf.

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