| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00847-1 |
| Product Name/Description |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS
Product code: GIF-1TH190
ARTG 112270
(OLYMPUS AUSTRALIA PTY LTD - Gastroduodenoscope, flexible, video) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has become aware of Ethylene Oxide Gas (EOG) sterilisation failure due to insufficient channel drying prior to the sterilisation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that Olympus has validated updated channel drying steps that will result in endoscope EOG sterilisation and will be provided with the updated instructions in the form of an addendum to the IFU.
Additional information 20/10/2023: The new drying steps are added following alcohol flushing and must be performed after each cleaning process even if the device is not sterilised using EOG sterilisation.
Olympus encourages customers to report any malfunctions, including adverse events and injuries associated with their devices to oaz-feedback@olympus.com for investigation.
This action has been closed out on 09/02/2024 |
| Contact Information |
1300 132 992 - Olympus Customer Operations |