Field Safety Notice Olympus Triangle Tip Knife J – Single Use Electrosurgical Knives   (ICN 3210)

NHSSC: 92

Alert:

• Olympus has issued a Field Safety Notice pertaining to the KD-640L and KD-645L Triangle Tip Electrosurgical Knives.
• After receiving complaints about the triangle tip breaking off during use, Olympus’ investigation determined that deterioration of the cutting knife, caused by overheating and burning, can contribute to tip breakage during use.
• Per the warnings in the Instructions for Use (within the notice), users should only activate the device output intermittently and should stop activating the output immediately if the device’s triangle tip turns red.
• The supplier is also notifying users of updates to the Instructions for Use (IFU) and labelling as noted in the notice.

Products Affected:

• The affected products are available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Keep a copy of the notice with the IFU for any affected devices remaining in your inventory.
• Complete the Acknowledgement Form, found page 5 of the notice, and return to: ra@olympus.co.uk
• If you encounter a breakage of the electrosurgical knife triangle tip, please raise a product complaint.
• See our Useful Links section to access the product complaint form.

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.