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
Image of 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: LF1537
Lot Numbers: 188856 and 190307 through 193333
Description: 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