| IRIC | Incident Reporting & Investigation Centre |
For action
DL1 NHS incidents and alerts safety officers
For information
DL2 Local authority incidents and alerts safety officers
DL3 Specialist Liaison Group
DL4 IRIC product specialists
DL5 General list (internal)
DL7 General list (external)
| Outlook tags | IRICSW$i0 (safety alert – general), IRICSW$i9 (device safety information) |
| Reference: | DSI/2025/001 |
| Subject: | Suzhou Surgicare disposable Hysteroscopy Sheath – recall due to withdrawn CE certificate |
MHRA has published the attached Device Safety Information (DSI) in partnership with devolved administrations. It applies across the UK and within Scotland it should be implemented by local authorities, health boards and contractors providing publicly funded health and social care services.
A PDF version of the alert is attached. You can also view a web version on the MHRA website at: https://www.gov.uk/drug-device-alerts.
Onward cascade
As the nominated person for your organisation, you need to identify managers and staff in your organisation who need to know or be aware of this alert and cascade it onward to them. The cascade should include all contractors and private or independent service providers who provide affected care, staff, equipment, buildings or other services or facilities for the direct care of patients or service users.
Adverse Incidents
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices (e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator)
- In vitro diagnostic devices or IVDs (e.g. blood analyser, reagent, SARS-CoV-2 test kit)
- Estates and facilities (e.g. electrical installations, window restrictors, nurse call systems)
- Social care equipment (e.g. mobile wheeled commode, powered rise and recline chair)
- Personal protective equipment or PPE (e.g. visors, FFP3 respirators, aprons)
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/.
Enquiries
If you have any enquiries in relation to this alert please email nss.iric@nhs.scot quoting the alert reference number in the message subject line, or call the IRIC Helpline 0131 275 7575. Alternatively, if you have received this message from someone in your own organisation, please direct all enquiries to them and they will liaise with IRIC as required.
Incident Reporting & Investigation Centre (IRIC)
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575 | Email: nss.iric@nhs.scot
IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Visit our website to report an incident and find our safety alerts.
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026
FAC406-276, 7D(vi), Rev 6
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