Medicines Healthcare Products Regulatory Agency
Manufactured by Olympus Medical Systems Corp instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.
Identify if you have any of the affected models listed in the manufacturers Field Safety Notice (FSN).
Inspect all potentially affected devices for frayed elevator wires.
Remove from service and quarantine any devices with frayed or damaged elevator wires and contact the manufacturer to arrange for repair, as stated in the instructions for use (IFU) of the device.
Attach the updated IFU from the FSN to existing device documentation.
Implement the pre-use inspections described in the updated IFU and ensure all relevant staff are trained in the new procedures.
Continue to remove and quarantine all devices identified as having frayed or damaged elevator wires.
Complete and return the manufacturer response form in the FSN.
Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
All staff responsible for the use and reprocessing of the device.
Deadlines for actions
Actions underway:12 March 2020
Actions complete:23 April 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Olympus MedicalMs Lucas - Regulatory Affairs Associate
Fax: 01702 465 677
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland) CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Clinical governance leads
- Community hospitals
- Day surgery units
- EBME departments
- Equipment stores
- Equipment libraries and stores
- Gastroenterology departments
- Gastroenterology, directors of
- Gastro-intestinal surgeons
- General surgeons
- General surgery
- General surgical units, directors of
- Operating department practitioners
- Outpatient theatre nurses
- Point of care testing co-ordinators
- Risk managers
- Sterile services departments
- Supplies managers
- Theatre managers
- Theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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 Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2020/008 or 2019/011/015/291/002.
Technical aspectsBen Satchell, MHRATel:020 3080 6000Email:DSS-TM@mhra.gov.uk
Clinical aspectsDevices Clinical Team, MHRATel:020 3080 7274Email:firstname.lastname@example.org
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)Tel:028 9052 3868Email:email@example.comTo report an adverse incident involving a medical device in Northern Ireland use the forms on the website.Alerts in Northern Ireland are distributed via the NICAS system.
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services ScotlandTel:0131 275 7575Email:firstname.lastname@example.orgTo report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.For more information, or if you cant access the webform, visit the website: how to report an adverse incident
Population Healthcare Division, Welsh GovernmentTel:03000 255278 or 03000 255510Email:Haz-Aic@gov.wales
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).