Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001
The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold without evidence of safety and have been manufactured to unknown standards. They may also be labelled as Gemini Medical Innovations.
Devices details
The affected devices are:
- Insulated Medium Cusco Speculum with smoke tube (REF GEM/6171)
- Gynaecological set hysteroscopic sheath (REF SPHS1870)
You can find pictures of the affected devices to help with identification here.
All lots and batches are affected.
Manufactured by Gemini Surgical UK.
Summary
The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold without evidence of safety and have been manufactured to unknown standards. They may also be labelled as Gemini Medical Innovations.
Due to the unknown potential risks to patient safety, MHRA wants to ensure that necessary steps are taken to safeguard public health by ceasing the use of these devices in the UK. It is important that you inform all relevant departments and ensure that the required actions are carried out.
Actions for the Patient Safety Lead in Healthcare Institutions. To be completed by 28 February 2022.
- Nominate a lead person to take responsibility for completing these actions. Note – we recommend including colleagues in purchasing, supplies, gynaecology, and the Medical Device Safety Officer (MDSO).
- Identify if your organisation has purchased or received samples of these devices
- Stop using these devices and use a suitable alternative
- Remove and quarantine any affected devices from all locations in your organisation
- Complete and return this online form to MHRA
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.
Information for patients
There are no actions for patients, your healthcare organisation will identify and remove any affected devices. If you are concerned, then please speak to your healthcare professional.
If you think you suffered from adverse effects having undergone treatment using any medical device, you can report to the MHRA via the Yellow Card Scheme: https://yellowcard.mhra.gov.uk/
Further information
If you have any specific concerns or additional information about this issue, you can contact MHRA on devices.compliance@mhra.gov.uk