Medical Device Alert: Electrosurgery disposable active electrodes and accessories manufactured by ConMed Corporation (MDA/2013/008)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/008 or 2012/012/028/291/019

Technical aspects
Elke Kerwick and Paul Sandhu
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 6826/7266
Fax: 020 8754 3965
Email: elke.kerwick@mhra.gsi.gov.uk or paul.sandhu@mhra.gsi.gov.uk

Clinical aspects
Mark Grumbridge
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email: mark.grumbridge@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Potential risk of intra-operative infection from a breach in the sterile packaging.

The packaging breach may not be easily seen by the user, especially if the electrode does not protrude from the package.

ConMed is recalling affected devices.

• Identify affected devices from the list in the manufacturer’s Field Safety Notice (dated 8 January 2013).
• Do not use affected devices.
• Quarantine and return all affected devices to the manufacturer.
• Complete and return the manufacturer’s acknowledgement form.

Action by

• Operating theatre staff.
• Surgeons.
• Supplies department staff.

This MDA has been sent to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters) for information
• Health Protection Agency (HPA) (directors)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (equipment coordinators)
• Local authorities in Scotland (equipment coordinators)
• NHS boards and trusts in Wales (chief executives)
• Primary care trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Cardiothoracic surgeons
• Clinical governance leads
• Colposcopy departments
• Day surgery units
• Dermatologists
• EBME departments
• ENT surgeons
• Gastro-intestinal surgeons
• General surgeons
• Infection control departments
• Infection prevention and control directors
• Medical directors
• Nursing executive directors
• Oral surgeons
• Orthopaedic surgeons
• Outpatient theatre nurses
• Paediatric surgeons
• Paediatric surgery, directors of
• Plastic and reconstructive surgeons
• Purchasing managers
• Risk managers
• Sterile services departments
• Supplies managers
• Theatre managers
• Theatre nurses
• Theatres
• Urological surgeons

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

• Community hospitals
• General practitioners
• Infection control nurses
• Practice managers
• Practice nurses

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Cal Murray
QA/RA Manager
ConMed UK
73/74 Shrivenham Hundred Business Park
Swindon
Wiltshire
SN6 8TY

Tel: 01793 787918
Fax: 01793 784568
Email: cmurray@linvatec.com

For any regulatory questions or enquiries outside the UK please contact:
Patricia Cotter
FRA Coordinator
ConMed Corporation
525 French Road
Utica, NY 13502
United States of America

Tel: 1-315-624-3237
Fax: 1-315-624-3225
Email: ultrablade@conmed.com