Field Safety Notice Creo Medical ScopeSnare FAL24532 and FAL24522 (ICN 3340)

NHSSC: 12

Update:

• Creo Medical has shared a Field Safety Notice issued by their manufacturer Transmed affecting Single Use Cold Snares.
• The notice is to make customers aware during endoscopic polypectomy with the Single Use Cold Snare, there is a potential risk of unilateral or complete detachment of the snare loop.
• The manufacture advises the primary cause may be that large lesions subject the wire to excessive tensile force during the cutting process.
• If the snare loop detaches, the exposed sharp wire theoretically presents a potential risk of scratching the digestive tract, causing peroration, or bleeding.

Products Affected:

• Four products are affected.
• Two products affected are available via NHS Supply Chain’s eDirect route:

• Please see the attached letter from Creo Medical advising which lots have received reports of the issue.
• Customers can review the attached product listing for information on the affected product and potential indirect alternatives.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow all instructions in the Field Safety Notice including the recommended procedures for two failure scenarios.
• Customers are advised to be aware of any potential issues with the affected products.
• If any product concerns arise, please notify NHS Supply Chain via our product complaints route.
• See our Useful Links section to access our Product Complaint Form.

NHSSC: 12

• NHS Supply Chain has been made aware of a further lot of FAL24532 – Cold ScopeSnare from Creo Medical may be affected having received customer product complaints:
  • Lot – ME251122M303.
• If any product concerns arise, please notify NHS Supply Chain via our product complaints route.
• See our Useful Links section to access our Product Complaint Form.

NHSSC: 12

Alert:

• NHS Supply Chain has been made aware of a potential safety concern with specific lots of Creo Medical Cold ScopeSnare having received customer product complaints.
• Whilst working with the supplier, we are making customers aware of the potentially affected products.

Products Affected:

• One product is affected.
• The one product affected is available via NHS Supply Chain eDirect route:

• Customers can review the attached product listing for information on the affected product and potential indirect alternatives.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Customers are advised to be aware of any potential issues with the affected products.
• If any product concerns arise, please notify NHS Supply Chain via our product complaints route.
• See our Useful Links section to access our Product Complaint Form.
• We will update this ICN with more information and guidance as it becomes available.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.