Ligasure blunt tip laparoscopic sealer/divider - potential risk of serious thermal burns

(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)

Device

Ligasure blunt tip laparoscopic sealer/divider

Ligasure blunt tip laparoscopic sealer/divider.

Manufactured by Covidien.

Catalogue number: LF1537.

Specific lot numbers.

Problem

During diathermy (electrosurgery) procedures the device may spontaneously energize when clamping, without the activation button being pushed.

Although no injuries have been reported, this could cause an unintended energy delivery to tissue resulting in serious thermal burns.

Action

The manufacturer is conducting a recall of specific lots.

  • Identify affected devices from the lot numbers indicated on the Field Safety Notice (see appendix).
  • Quarantine any affected devices and arrange for their return to Covidien.

The MHRA is issuing this alert as there has been a poor response from users to the recall.

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Health Protection Agency (HPA) (directors)
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (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:

  • Clinical governance leads
  • Day surgery units
  • Equipment stores
  • Gynaecological surgeons
  • Gastro-intestinal surgeons
  • General surgeons
  • General surgery
  • Medical physics/EBME
  • Medical directors
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Purchasing managers
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

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

  • Clinical governance leads
  • Community hospitals
  • Practice managers

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
  • Treatment centres

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.

Manufacturer contact

Covidien (UK) Commercial Ltd
154 Fareham Road
Gosport
Hampshire
PO13 0AS

Tel: 01329 224000
Fax: 01329 224418

Email: PRMS.ComplaintsDepartment@covidien.com

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk

Appendix

December 10, 2001

URGENT: FIELD SAFETY CORRECTIVE ACTION
PRODUCT RECALL

RE: LigaSureTM Blunt Tip Laparoscopic Sealer/Divider

Dear Valued Customer:

Coviden (formerly Valleylab, a division of Tyco Healthcare) is conducting a recall of specific lots of the LigaSureTM Blunt Tip Laparoscopic Sealer/Divider (Catalogue Number LF1537). This action is in response to reports that during surgical procedures the device may energise when clamping without pushing the activation button. Although no injuries have been reported, this issue could result in unintended energy delivery to tissue. Coviden is requesting that customers quarantine and return any remaining stock of the lots listed below.

THIS RECALL APPLIES ONLY TO THE PRODUCT CATALOG NUMBER AND LOT NUMBERS LISTED BELOW. No other lots or product codes of LigaSureTM Blunt Tip Laparoscopic Sealer/Divider are affected by this recall.

 Cataloguer Number/Product ID    Lot Numbers    Description
 LF1537    188856 and 190307 through 193333    LigaSureTM Blunt Tip Laparoscopic Sealer/Divider

Should any of the listed products be found, please remove them from inventory and place in quarantine immediately.

We ask that you reply to Coviden WHETHER OR NOT you have affected product at your site, using the enclosed Customer Response Form. Your response is vital to our monitoring of the effectiveness of this recall.

Please use the attached form, even to confirm if you have no inventory remaining, return any identified product for replacement.

Should you have any medical questions concerning this recall, please contact your local sales representative or Justin Rogers, Product Manager, telephone mob: 07734286275.

This action is being conducted with the knowledge of the Medicines and Healthcare products Regulatory Agency (MHRA). We apologize for any inconvenience this action may cause, and sincerely appreciate your understanding and cooperation.

Sincerely

Customer Response FormCustomer Response Form

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/026 or 2010/012/009/081/002.

Technical aspects

John Ward or Mel King
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7232 / 7286
Fax: 020 8754 3965

Email: john.ward@mhra.gsi.gov.uk or mel.king@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7128
Fax: 020 8754 3965

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 .

Northern Ireland

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

Northern Ireland Adverse Incident Centre (NIAIC)

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website .

Further information about SABS can be found on the SABS website .

Scotland

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

Wales

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 3922

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

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