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TGA Action ID	RC-2026-RN-00721-1
Type of Product	Medical Device
Product Name/Description	Single Use Ligating Device Polyloop Model: HX-400U-30 SKU: N5382130 Lot Numbers: 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 4ZV, 51V, 52V, 53V, 54V, 55V, 56V, 57V, 58V, 59V, 5XV, 5YV, 5ZV, 61V, 62V, 63V, 64V, 65V, 66V
ARTG Number	145846
Unique Device Identifier (UDI)	0495317036861
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Olympus previously communicated a Product Correction (RC-2025-RN-00932-1) related to additional clarifications in the Instructions for Use (IFU) for proper release of the Single Use Ligating Device. Alternatively, customers may have received a Notification of IFU Change with recently purchased products. The action was taken based on complaints from customers indicating that 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. Globally Olympus previously received one hundred and seventy (170) reports of serious injuries related to this problem and no reported deaths. Olympus is introducing a design change to address complaints that the ligation loop was unable to release or detach as expected during use, with operation pipe breakage being one of the contributing factors to these complaints.
Instructions for Customers/Users	Customers are to: • Examine their inventory for the affected Lot Numbers. Affected are the older versions of this product that are still within the expiry date and should be returned to Olympus. • Transition to the newly designed version as soon as possible by placing an order through their normal ordering process. While awaiting the delivery of the new design, customers are to follow the updated instructions for use. • Once the new design is received, stop using the old design and quarantine for return to Olympus. Please note, a product return does not automatically trigger a product replacement for the new design product. Customer will need to place a new purchase order with Olympus Australia through their usual ordering processes, should they wish to order stock of the new designed product.
Action Commencement Date	23/09/2026
Responsible Entity	Olympus Australia Pty Ltd
Contact Information	1300 132 992 - Olympus Customer Operations