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TGA Action ID	RC-2025-RN-00109-1
Type of Product	Medical Device
Product Name/Description	Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Model numbers: VH-4000, VH-4001 All unexpired lots
ARTG Number	161672
Unique Device Identifier (UDI)	00607567700406, 00607567700451
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Two failure modes may be experienced during use: 1. A bent or detached heater wire 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool. Peeling or detachment of silicone from the Jaws can cause the tool to malfunction. If the Jaw Heater Wire becomes compromised, bent, or detached, it could potentially harm the patient: -Procedure delays, retrieve detached silicone, or set up a new device. -Additional interventions to retrieve detached material, complete the vessel harvest, address bleeding, and/or harvest additional conduit. -Bleeding due to incomplete cauterization or damage. -Burns to vessel, conduit, or tissue from damaged Jaw material. -Retained detached silicone within the body cavity. If unnoticed or not removed, detached silicone can cause future complications, including delayed pain, infection, localised allergic reactions, and/or readmission for further medical or surgical intervention.
Instructions for Customers/Users	Update 18/07/2025: The following statements have been added to the IFU: - While maintaining the angle of the Tool Adapter port, slowly insert the Harvesting Tool. Do not apply excessive force while inserting the Harvesting Tool. - Carefully remove Hemopro 2 EVH System from its shipping package. Do not use if damaged or opened. Inspect entire device including Harvesting Tool Jaws to ensure no damage has occurred during transit or storage. - Soak a soft, sterile fabric such as a gauze with normal saline. - Moisten the Jaws with the wet gauze on conclusion. - Place the device in a secure and sterile location on the sterile table to avoid damage while not in use. - NOTE: Use a slow and steady approach during use of the Harvesting Tool. Rapid continuous activations of the tool may degrade the silicone over time or engage the safety shut down mechanism noted below. - Take care when cleaning the Jaws. Damage may occur with improper cleaning. This action has been closed out on 01/09/2025
Action Commencement Date	20/03/2025
Responsible Entity	Getinge Australia Pty Ltd
Contact Information	1800 438 464 - Getinge Customer Support