Olympus Single Use Ligating Device PolyLoop ™ priority 2 - Warning
22/12/2025
Medical devices
HPRA safety notice
| Point of information | Details |
| Device Manufacturer Information | Olympus Medical Systems Corporation. |
| Target Audience | Healthcare professionals and healthcare settings involved in the use and/or provision of these devices. |
| What devices are affected? | All lots of Olympus Single Use Ligating Device PolyLoop Model Number HX-400U-30, Catalogue Number N5382130 |
Problem or issue?
Following complaints from customers, the manufacturer has identified an issue where the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. There have been no reports of this issue from the market in Ireland to date.
What is the risk?
The associated risks include moderate to severe tissue/mucosal injury, bleeding, potentially requiring transfusion, perforation, the need for additional surgical intervention, extensive procedural delays, and hospitalisation.
Why is the HPRA issuing this safety notice?
The HPRA is issuing this safety notice to highlight the field safety notice issued by Olympus which reminds users of the existing warnings and cautions in the Instructions for Use and provides supplemental guidance regarding the use of the device. Olympus is continuing to investigate this issue to identify and address any applicable causes and plans to issue additional communication following the investigation.
What advice has the HPRA for users of these devices?
- Please read the content of the accompanying FSN (linked at the bottom of the page), including the supplemental guidance and reinforced text from the IFU.
- Always have Olympus loop cutter available when using the PolyLoop Device.
- Ensure all personnel are thoroughly aware of the information in the FSN when using the affected devices.
- Ensure that a copy of the FSN and the supplemental guidance is given to all users and to all those that need to be aware within your organisation or to any organisation / person where these devices have been transferred.
- Acknowledge the receipt of the FSN through the reply form.
Contact information
| Manufacturer | Authorised Representative | Distributor | |
| Name: | Olympus Medical Systems Corporation | Olympus Europa SE & Co. KG | Olympus Ireland |
| Address: | 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan, 192-8507 | Wendenstrasse 20, Hamburg, Germany, 20097 | KeyMed House, Unit G8, Calmount Business Park, Ballymount, Dublin12 |
| Email: | fca-emea@olympus.com | fca-emea@olympus.com | niamh.billings@olympus.com |
| Telephone: | +81-42-642-5177 | +49-40-23773-3239 |
HPRA Contact Information
All safety issues relating to medical devices should be reported to the HPRA using any of the following reporting options:
- HPRA online report form
- Telephone: +353-1-6764971
Further information on the role of the HPRA in relation to medical devices is available on the regulation of medical devices section of the HPRA website.
Any enquiries regarding this safety notice or any medical device safety issue should be emailed to us using our online contact form.
Documents
Opens in new window Olympus Medical Systems Corporation _Olympus Single Use Ligating Device PolyLoop _Priority 2_Warning_HPRA Safety Notice PDF : 144KB | 22/12/2025 Opens in new window Olympus Medical Systems Corporation _Olympus Single Use Ligating Device PolyLoop _FSN PDF : 712KB | 22/12/2025Product images
