- Medicines and Healthcare products Regulatory Agency
- 18 February 2015
- 18 February 2015
- Alert type:
- Medical device alert
- Medical specialty:
- Theatre practitioners
(Integra LifeSciences) Risk of burns to user if the blue COAG button on the CUSA Excel CEM nosecone sticks in the ‘activated’ position. (MDA/2015/005)
Ensure that all users:
- identify affected devices
- are aware of the updated advice and guidance detailed in the manufacturer’s re-issued field safety notice (FSN) dated 12 December 2014
- have spare nosecones readily available for use
- complete and return the manufacturer’s acknowledgement form in the FSN
- use alternative devices where possible
- report any adverse incidents to Integra LifeSciences and MHRA through the Yellow Card scheme
- operating theatre staff.
- supplies department staff
Action underway: 4 March 2015, action completed: 18 March 2015
CUSA CEM nosecones for use with the CUSA Excel/Excel+ ultrasonic aspirator.
Product codes: C6623 and C6636.
The blue COAG button on the CUSA Excel CEM nosecone can stick in the ‘activated’ position. Integra has received a number of complaints of tissue burn because of this problem.
The FSN reminds users about important safety information and provides clarification on device activation times. However, Integra has not received enough responses from users that they have received and acted on this information.
Integra is currently validating a new design, and new product should be available by June 2015.
Telephone: +33 (0)4 37 47 59 00
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- all surgeons
- biomedical engineering staff
- clinical governance leads
- equipment stores
- health and safety managers
- maternity units
- medical directors
- purchasing managers
- risk managers
- supplies managers
- theatre managers
- theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only). The 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: firstname.lastname@example.org and requesting this facility.
If you are in England send enquiries about this notice to MHRA, quoting reference number MDA/2015/005 or 2013/012/023/291/021.
Patrick Sweeney or Paul Sandhu, MHRA
Tel: 020 3080 6898 / 7266
Mark Grumbridge MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
Through Yellow Card https://yellowcard.mhra.gov.uk/
Alerts in Northern Ireland are distributed via the NI SABS system.
Address enquiries and adverse incident reports in Northern Ireland to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Fax: 028 9052 3900
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and local authorities in Scotland should report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should also report to Health Facilities Scotland.
Address enquiries in Wales to:
Healthcare Quality Division, Welsh Government
Tel: 01267 225278 / 02920 825510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card scheme and follow specific advice for reporting MDA/2004/054 (Wales).
Published: 18 February 2015
Issued: 18 February 2015
Alert type: Medical device alert
Medical specialty: Theatre practitioners