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
Image of Stapler Duet TRS™ 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 (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 (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
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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