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 |
|
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 |