| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00818-1 |
| Product Name/Description |
OFP-2 Flushing Pump
Product Code: K10001145
Serial Numbers: 22323196 - 22415056
ARTG 355612
(Olympus Australia Pty Ltd - Surgical irrigation pump) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Olympus Australia Pty Ltd has identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. If the connection failure occurs, the OFP-2 device will return to or remain in the “Off” condition and the operator will not be able to use the flushing function.
This can lead to a delay in initiating the procedure or a prolong in the procedure as the end user needs to either replace the device and/or elect to complete the procedure with alternative methods of endoscopic irrigation available in the procedural room setting.
No adverse events have been reported. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. Inspect inventory and identify any OFP-2 devices with serial numbers 22323196 to 22415056 (the serial number can be found on a label affixed to the back of the OFP-2 pump).
2. Following receipt of the completed form, an Olympus representative will contact the customers to arrange for the inspection of the device and repair if needed.
3. Customers may continue to use the product until it is inspected by an Olympus Representative. |
| Contact Information |
0403937679 - Emma Flett |