Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00197-1
Product Name/Description ENDOEYE HD II Rigid Videoscope

Item Codes: WA50040A and WA50042A

All Serial Numbers

ARTG Number: 121101
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 9/02/2017
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue Olympus is extending the previous recall for product correction (TGA Ref.: RC-2015-RN-01141-1) from selected serial numbers to all serial numbers in the market. ENDOEYE distal end can under certain circumstances become hot if the temperature sensor at the device’s tip is damaged (a mechanical breakage of the temperature sensor). Although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the ENDOEYE distal end could result in patient or user injury.

As part of the previous action selected serial numbers had the fog-free function disabled due to the backup mechanism (software) designed to detect and identify the failed temperature sensor was not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. This was shortly followed by phase II correction to replace the hardware (cable) and restore full functionality of the fog-free function.
Recall Action Recall for Product Correction
Recall Action Instructions Users are advised to discontinue the use of any affected devices in their inventory. Olympus Field Service will schedule a time for to deactivate the fog-free function on the device. The visualisation of the devices will be unaffected and they can be immediately returned to routine use following correction. Customers will be notified once Olympus has concluded the technical investigation and established the permanent solution.

This action has been closed out on the 25/09/2018.
Contact Information 03 9265 5591- Olympus Australia