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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00935-1
Product Name/Description	ENDOEYE HD II Product codes: WA50040A and WA50042A All serial numbers ARTG 121101 (OLYMPUS AUSTRALIA PTY LTD - Laparoscope, rigid)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/11/2023
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Olympus has become aware of complaints, including adverse events related to pink or green colouration of the image, including cases with reported delays of treatments and/or prolonged surgery. The imaging colour is an important factor affecting visualisation in laparoscopic procedures to recognise relevant tissue areas for treatment. When an image discolouration is detected prior to a procedure, it is expected that the device will require replacement, leading to a delay in patient treatment. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery, and due to potential visual impacts mucosal injury or bleeding may occur. Olympus is currently investigating technical solutions to address this issue.
Recall Action	Product Defect Alert
Recall Action Instructions	Olympus is currently investigating a technical solution to address this issue and customers will be notified when the solution is available. In the interim customers and medical personnel are follow the instructions in the ENDOEYE HD II IFU, especially the need to inspect the image prior to a clinical procedure (as described in Section 7.4 Testing), always have a spare laparoscope available (as described in Section 2.5 General Dangers, Warnings and Cautions) and to check the image on the spare equipment.
Contact Information	1300 132 992 - Olympus Customer Operations