- Identify affected devices from the lists in the electrode and forceps field safety notices (FSNs) and quarantine those in stock
- Fill in the customer response form and return it to Zethon
- Return affected stock to Zethon
Surgeons, theatre managers, operating theatre and supplies staff.
Deadlines for action
Actions underway: 10 September 2015, actions complete: 24 September 2015
Telephone: 01296 634 090
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- cardiothoracic surgeons
- cardiothoracic surgery directors
- clinical governance leads
- day surgery units
- EBME departments
- equipment stores
- equipment libraries and stores
- gastro-intestinal surgeons
- general surgeons
- general surgery
- general surgical units, directors of
- gynaecology departments
- gynaecology nurses
- health and safety managers
- infection control departments
- infection control nurses
- maxillofacial departments
- obstetrics and gynaecology departments
- obstetrics and gynaecology directors
- obstetrics departments
- obstetrics nurses
- oral surgeons
- orthopaedic surgeons
- paediatric surgeons
- paediatric surgery, directors of
- purchasing managers
- sterile services departments
- supplies managers
- theatre managers
- theatre nurses
- urological surgeons
- urological surgery, directors of
Establishments registered with the Care Quality Commission (CQC) (England only):
- hospitals in the independent sector
- independent treatment centres
- private medical practitioners
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.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/033 or 2015/006/030/291/002. or 2015/006/030/291/004.
Paul Sandhu, MHRA
Telephone: 020 3080 7266
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
Through the Yellow Card website.
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Report directly to NIAIC using the forms on the website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 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 report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624 / 02920 825 510