| 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 |
|
| 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 |