| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01519-1 |
| Product Name/Description |
Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope
Model Numbers: URF-V2 and URF-P6
ARTG Numbers: 211118 and 131068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
OMSC has received a small number of adverse event reports globally for the URF-V2 associated with damage to the bending section. To date, no adverse events have been reported to Olympus in Australia for the URF-V2 and no adverse events reported globally for the URF-P6.
Further to Olympus’ Safety Alert issued in December 2016 (RC-2016-RN-01653-1), the manufacturer has modified the design of the bending section of the URF-V2 and URF-P6 to address any deficiencies that may have attributed to the adverse events reported globally. |
| Recall Action |
Recall |
| Recall Action Instructions |
Olympus is advising hospitals to identify affected devices from their inventory. When replacement URF-V2 and URV-P6 devices are available, an Olympus Customer Operations Specialist will contact users to exchange devices at affected facilities. In the interim, users may refer to the IFU and Safety Alert issued by Olympus for the correct inspection and use of the device.
This action has been closed out on 09/08/2019 |
| Contact Information |
1300 657 699 - Olympus |