Field Safety Notice Olympus Triangular Tip Electrosurgical Knives (ICN 2471)

Alert:

• Olympus has issued a Field Safety Notice following an increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use.
• The Triangle Tip Electrosurgical Knives are single-use and are designed to be used with Olympus endoscopes and electrosurgical units.
• Investigation by Olympus has identified the deterioration of the cutting knife can contribute to breakage during use. Deterioration, including overheating or burning, may occur due to use with non-Olympus electrosurgical units and/or the use of output settings that exceed the specifications detailed in the Instructions for Use.
• Use of devices or settings that are inconsistent with the specifications listed in the Instructions for Use may lead to patient harm including device fragments breaking off inside the patient, burns, perforation, or foreign body reaction.
• Olympus has issued the Field Safety Notice to remind users to utilize devices in accordance with the instructions for use, which detail critical specifications regarding electrosurgical unit compatibility and output.

Products Affected:

• The products affected 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.
• Complete and return the Reply Form, page 3 of the Field Safety Notice as soon as possible by emailing: OlympusFY24-40@Sedgwick.com
• 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 or 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.