Medical Device Alert: Universal cables for use with ConMed Linvatec surgical power tools (MDA/2010/003)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/003 or 2009/008/024/081/009.

Technical aspects:
Paul Sandhu or Catriona Blake
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3266/3219
Fax: 020 7084 3209

Email: paul.sandhu@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects:
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3123
Fax: 020 7084 3111

Email: jonathan.plumb@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 Central Alerting System 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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

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 (external link)

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

Email: Haz-Aic@wales.gsi.gov.uk

There is a possibility that a worn or damaged power cable may cause the handpiece to self-activate.

ConMed Linvatec issued a Field Safety Notice on this problem in September 2009.

• Identify affected devices.
• If you have any affected devices, contact ConMed Linvatec for replacement cables.
• While waiting for replacement cables:
• • follow the manufacturer’s instructions, which state: 'Always inspect cord for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately.'
  • test the cable by inserting the cable into the power tool prior to use, away from the surgical site
  • the user should avoid contact with moving parts on the handpiece when the cable is connected in case there is an unexpected activation of the handpiece.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• Clinical governance leads
• Day surgery units
• ENT services, directors of
• Equipment stores
• Health and safety managers
• Medical directors
• Nursing executive directors
• Orthopaedic surgeons
• Purchasing managers
• Risk managers
• Supplies managers
• Surgeons
• Theatre managers
• Theatre nurses
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Independent treatment centres

Ms Cal Murray
ConMed Linvatec UK
73/74 Shrivenham Hundred Business Park
Watchfield
Swindon
Wiltshire
SN6 8TY

Tel: 01793 787918
Fax: 01793 784568

Email: cmurray@linvatec.com