Field Safety Notice Lawmed Ltd Airseal Access Points (ICN 3376)

NHSSC: 26

Alert:

• Our supplier Lawmed Ltd has shared a Field Safety Notice issued by CONMED updating their Instructions for Use (IFU), following an increase in reports of overpressure alerts with AirSeal Access Ports, which in some cases have resulted in delay of treatment.
• During a review of complaint data, CONMED identified that a previous manufacturing process update may, under certain conditions, contribute to overpressure alerts. In response, the Instructions for Use (IFU) have been clarified to ensure proper device tightening.
• In the event of an overpressure condition, AirSeal is designed to respond automatically via a built-in venting system, which activates when the pressure exceeds the set point by more than 3 mm Hg for more than 3 seconds. When the “overpressure” alert is displayed there is a higher-than-expected pressure within the system between the AirSeal® iFS and the AirSeal access port but does not represent higher-than-expected pressure within the patient.
• The reported incident may result in the loss of pneumoperitoneum due to the system venting gas to compensate for the overpressure. Loss of pneumoperitoneum may result in loss of field of view, which may lead to iatrogenic injury, more complex or converted procedures, and/or delay of treatment.
• Potential risk associated with a true overpressure could include air embolism, arrythmias (bradycardia, asystole, or cardiac arrest), pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, delay to treatment, more complex procedures, and potentially death.
• CONMED confirm they have received no reports of patient or user injury or death associated with these overpressure alerts.

Products Affected:

• Eleven products are affected
• The eleven affected products are or have previously been available via NHS Supply Chain’s eDirect service.
• Please refer to the attached product listing for more information on the products affected.
• The affected products were manufactured between 14 June 2024 and 12 June 2026, lot numbers 202406144 through to 202601124.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share, together with the updated IFU AS-DIS-IFU Rev B 03-2025 with all users of the affected products.
• Dispose of any other Instructions for Use in your possession. Clarification of the IFU is meant to assist all customers when using the AirSeal Access Ports correctly.
• Copies of the corrected IFU are also available electronically for each of the AirSeal Access Ports at: conmed.com/eifu.
• If you have provided these devices to other facilities please forward this information as appropriate. It is imperative that all end users of these devices receive this notice.
• Complete the Customer Reply form, Appendix A, page 4 of the Field Safety Notice and return to: accessports2026@conmed.com.
• Please note that this is not a product recall. Products may continue to be used in accordance with the updated IFU, and the actions outlined within the Field Safety Notice.

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.