Field Safety Notice Cook Medical Instinct Plus Endoscopic Clipping Device FAL85003 (ICN 3039)

NHSSC: 54

Alert:

• Cook Medical has issued a Field Safety Notice following reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle of the Instinct Plus Endoscopic Clipping Device.
• The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire but will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs
• Potential adverse effects to the patient that may occur if the clip does not deploy as intended are injury (bleeding, laceration, perforation, etc.) to the patient requiring additional interventions. Potential adverse effects to the patient that may occur if there is a significant delay in the hemostasis procedure are additional interventions or medications needed to stabilize the patient, bleeding requiring additional hemostasis, surgical intervention hospitalization, or death. Additionally, the device failure may result in inability to open the clip, deployment of the clip without being attached to tissue, or the malfunction could be recognizable prior to use and the device would be replaced with an insignificant delay in procedure and the potential for injury unlikely.

Products Affected:

• The affected product is 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.
• This action is not a removal of devices from the field. Cook Medical advise the devices may continue to be used, taking these risk mitigation actions into consideration:
  • The Instructions for Use (IFU) states “Precaution – Do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip” and “With clip closed and without holding handle spool advance device in small increments into accessory channel of gastroscope, duodenoscope, or colonoscope… Holding handle spool during clip advancement may prematurely deploy clip”.
  • The user should follow the IFU for proper preparation and use of the device. Please refer to Page 3 of the Field Safety Notice for specific details.
• Cook Medical advise they have contacted all affected customers. If you have not yet completed and returned the “Field Action Customer Reply Form” please do so as soon as possible.

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.