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Field Safety Notice Olympus Thunderbeat Jaw Breakage Issue FGE4025, FGE4026 and FGE4027 (ICN 2810)

Important Customer Notice Field Safety Notice

Ref: 2025/2810 ICN Number: 2810

 

NHSSC: 87

Alert:

  • Olympus has issued a Field Safety Notice following customer feedback reporting the probe tips of the Thunderbeat type S hand instruments becoming damaged or breaking, also instances of pad damage or breaking.
  • Olympus advise these issues can occur when the instructions and warnings in the Instructions for Use (IFU) are not followed, specifically, taking very large bites of tissue, contact with metal while activating, and activation without tissue between the jaws.
  • Not replacing the instrument per the IFU can cause probe damage/breakage and pad damage/detachment, which can result in patient harm of foreign body in the patient, requiring imaging and prolonged operative time or an additional procedure to locate and remove the broken piece.
  • Additionally, tissue damage and bleeding could occur due to exposed sharp edges. A broken piece remaining in the patient could potentially lead to an inflammatory reaction or granuloma.
  • The probe tip or tissue pad breaking due to high temperatures and falling into the patient, may cause thermal injury to the patient.

Products Affected:

  • These products are available on the eDirect Service via NHS Supply Chain:
NPC Product Description Supplier Code / MPC

UDI – DI

FGE4026

Energy Accessories TB-0535FCS Thunderbeat EGTB-0535FCS

04953170383540

FGE4025

Energy Accessories TB-0545FCS Thunderbeat EGTB-0545FCS

04953170383519

FGE4027

Energy Accessories TB-0520FCS Thunderbeat     N5423930 04953170383571

 Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this Field Safety Notice and the relevant Instructions for Use (IFU).
  • Olympus requests that you acknowledge receipt of this FSN, by indicating on the enclosed Reply Form, page four of the Field Safety Notice if you would like to receive in-service training to support the correct use of this device.
  • Also, demonstrating that you have received and understood this notification by completing all available fields in the Reply Form and returning it back to your local Olympus representative: ra@olympus.co.uk

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.

Download our publications ▼

  • 2810 Olympus Field Safety Notice 29 January 2025

    A PDF showing the Field Safety Notice for ICN 2810.