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Device details

Device name: Disposable Hysteroscopy Sheath

Affected lot serial numbers: All

Manufactured by: Suzhou Surgicare Medical Technology Ltd

Advice for Healthcare Professionals and Providers

• Review your inventory and determine if you have any affected devices.
• Immediately stop use, quarantine and stop supply of any identified product(s)
• Return unused stock to the distributor HJ Medical (GyneVision)
• Providers should ensure all relevant members of staff receive this safety information and that they understand the problem and actions to be taken.
• Report any suspected or actual adverse incidents involving these devices. »Ê¹ÚÌåÓýappre are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
  • in England and Wales to the or via the Yellow Card app
  • in Scotland to and their local incident recording system
  • in Northern Ireland to the and their local incident recording system

Advice for Healthcare Professionals to Provide to Patients

»Ê¹ÚÌåÓýappre is no advice for healthcare professionals to provide to patients regarding this DSI

Advice for Distributors

»Ê¹ÚÌåÓýappre is no advice for distributors regarding this DSI

Explanation of identified safety issue

»Ê¹ÚÌåÓýapp MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. »Ê¹ÚÌåÓýappse products are manufactured by Suzhou Surgicare Medical Technology Ltd and distributed by HJ Medical (GyneVision). »Ê¹ÚÌåÓýapp CE certificate was withdrawn by the manufacturer’s Conformity Assessment Body due to concerns relating to the manufacturer’s surveillance activities.

»Ê¹ÚÌåÓýapp Surgicare Disposable Hysteroscopy Sheath is intended to be used as a single-use operative sheath for use with the Flex-Eye HD hysteroscope, forming an integrated system designed to enable rapid diagnostic-to-therapeutic conversions during hysteroscopic procedures.

»Ê¹ÚÌåÓýapp MHRA has safety concerns relating to these products such as; the risk of infection and inappropriate sterilisation procedures.

Reporting advice

Healthcare professionals should report incidents:

• in England and Wales to the or via the Yellow Card app
• in Scotland to and their local incident recording system

• in Northern Ireland to the and their local incident recording system

Additional information:

You can sign up to receive email updates on alerts and device safety information from the MHRA.

Stakeholder engagement:

• Incident Reporting & Investigation Centre (IRIC) for Scotland
• NHS Wales
• Northern Ireland Adverse Incident Centre for Northern Ireland
• NHS England Patient Safety Team
• NHS Supply Chain

An advance copy for review was sent to all the devolved administrations for stakeholder engagement.

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