Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) - do not use for adult or paediatric thoracic surgery procedures

(Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)

CAS deadlines

Action underway: 01 March 2012, action complete: 08 March 2012

Device

Stapler Duet TRSTM universal straight and articulating single use loading units (SULU)

Stapler

Duet TRS™ universal straight and articulating single use loading units (SULU)

Manufactured by Covidien

Product codes and descriptions of affected devices:

Product code   Description
DUET4535   Duet TRS™ 45 3.5mm straight SULU
DUET4535A   Duet TRS™ 45 3.5mm articulating SULU
DUET4548   Duet TRS™ 45 4.8mm straight SULU
DUET4548A   Duet TRS™ 45 4.8mm articulating SULU
DUET6035   Duet TRS™ 60 3.5mm straight SULU
DUET6035A   Duet TRS™ 60 3.5mm articulating SULU
DUET6048   Duet TRS™ 60 4.8mm straight SULU
DUET6048A   Duet TRS™ 60 4.8mm articulating SULU

Problem

Covidien has issued advice (369Kb) following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.

These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening post-operative complications.

Action

  • Do not use these Duet TRSTM Loading Units for any adult or paediatric thoracic surgery procedures.
  • Return any products purchased solely for thoracic use to the manufacturer, following the instructions in the manufacturer’s advice (369Kb).

Action by

Thoracic surgeons, all surgical and theatre staff involved in the use of these devices.

Distribution

This MDA has been sent to:  

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (headquarters) for information
  • 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:

  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Clinical governance leads
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres
  • Thoracic surgeons
  • Thoracic surgery departments
  • Thoracic surgery directors

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

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

Amanda Woolven
Covidien Commercial (UK) Ltd
4500 Parkway
Whiteley
Hampshire
PO15 7NY

Tel: 01329 224 435
Fax: 01329 224 418

Email: Amanda.woolven@covidien.com

Feedback

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

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/005 or 2012/001/016/081/009

Technical aspects

Sally Mounter
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7168
Fax: 020 8754 3965

Email: sally.mounter@mhra.gsi.gov.uk

Clinical aspects

Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@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

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)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

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

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

Download documents

Medical Device Alert: Stapler Duet TRSTM universal straight and articulating single use loading units (SULU) manufactured by Covidien (MDA/2012/005) (359Kb)

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