Field Safety Notice Olympus HF Cable Thermal Event During Procedure (ICN 3524)

NHSSC: 79

Alert

• Olympus has issued Field Safety Notice FY26-018-F reusable cables after receiving a complaint involving a thermal event with HF cable WA00014A that caused a minor burn.
• The investigation found the cable had been used beyond its IFU-defined service life and was not inspected before use, resulting in insulation wear, corrosion, and failure.
• Following a March 2026 Field Safety Notice for WA00014A, not affecting NHS Supply Chain, Olympus identified 19 additional models that may experience the same failure; this notice addresses those models.
• Olympus identified 60 complaints potentially related to thermal events involving the 19 additional HF cable models over the past four years, with no serious injuries.
• Damage to the device cable can lead to loss of function, which may delay the start or completion of procedures. In addition, a compromised cable may expose users or patients to fire, heat, smoke, sparks, or electrical current, creating a risk of burns, smoke inhalation, or electric shock.

Products Affected:

• 19 products are affected.
• Of the affected products 6 products are currently available via NHS Supply Chain’s eDirect service.
• This is not a removal action. The devices may continue to be used as per this notice and the Instructions for Use.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• As stated in the Instructions for Use, do not use the device beyond the defined service life, and inspect all HF cables for mechanical defects prior to use.
• If any defects are identified, replace the cable, regardless of the first-use date or number of uses.
• Olympus requests that you acknowledge receipt of this letter. Acknowledge on the Reply Form Attachment 3, page 13 of the notice that you have received and understood this notification by completing and returning the enclosed Reply Form to your local Olympus representative at ra@olympus.co.uk by 16 November 2026.
• 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.