Field Safety Notice Intersurgical i-View Video Laryngoscope FDD5469 and FKK85020 (ICN 2977)

NHSSC: 37

Alert:

• Intersurgical has issued a Field Safety Notice regarding specific lots of i-View Video Laryngoscope having received reports of faulty devices resulting from depleted batteries.
• The Instructions for Use provided with i-View, include the pre-use check to turn on the device and check there is a visible light at the distal end of the blade and that the screen and camera are working correctly.
• The device must be discarded if it cannot be successfully switched on and off.
• The supplier has received a number of reports and believe it is necessary to remove the potentially affected products from the market, minimising inconvenience to users whilst addressing the issue promptly to further reduce the risk of any potential delays to treatment and any patient harm.

Products Affected:

• The affected product was available from NHS Supply Chain’s eDirect route:

•  Please note the two product codes are the same product but different pack sizes.
• The affected product codes are delisted and are no longer available to order from NHS Supply Chain.
• The affected devices were manufactured between January and July 2024.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Contact the supplier at to arrange collection of affected products by completing the Customer Reply Form, found page 5 of the notice, and return to priority@intersurgical.co.uk
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and lot numbers you are returning to the supplier to enable us to manage your credit where appropriate.

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.