| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00470-1 |
| Product Name/Description |
HF-Resection Electrode
Item Numbers: A6280, A6281, A6282, A6283, A6284, A6289, A6292, A6293, A6294, A6299
ARTG Number: 146187
(Olympus Australia - Electrosurgical system, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Olympus Winter & Ibe (OWI) became aware of complaints relating to signs of wear on the handle after sterilisation using the STERRAD and STERIS, ‘CASP low temperature plasma steriliser’.
During their investigation, the manufacturer confirmed that these signs of wear (slight changes in colour and structure) at the handle had occurred after the first time of sterilisation. Whilst the sterilisation has no impact on the electrical safety of the electrodes, it no longer meets the manufacturer’s material compatibility acceptance criteria when using the STERRAD and STERIS Sterilisation methods.
To ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the STERRAD and STERIS sterilisation methods, as such the IFU has been updated to change the compatibility to “incompatible” for the reprocessing methods STERRAD and STERIS |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Olympus is advising:
"To ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the STERRAD and STERIS sterilisation methods, as such the IFU has been updated to change the compatibility to “incompatible” for the reprocessing methods STERRAD and STERIS".
Users should inspect inventory for affected product and visually inspect the device prior to use as outlined in the IFU (section 5.1).
If users are reprocessing devices using the STERRAD or STERIS, please discontinue and change to using one of the compatible reprocessing methods. An updated IFU to reflect this will be provided to users.
This action has been closed out on 21/02/2019 |
| Contact Information |
1300 657 699 - Olympus Customer Operations |