| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01161-1 |
| Product Name/Description |
HF Cable used with ESG-400 Electrosurgical Generator (bipolar)
Product Code: WA00014A
ARTG Number: 194874 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Olympus is notifying users of the reoccurrence of potential error codes for the Olympus WA00014A HF Cable. Although procedures can continue by troubleshooting and clearing error codes in accordance with the ESG-400 Instructions for Use (Section 8.2), Olympus is highlighting instances of the following error codes when the device is connected:
- E618 ‘Data transfer’,
- E486 ‘No instrument connected’; or,
- a pop up message ‘use default instrument settings’
There have been no Australian reports of these error codes or incidents with patient injury worldwide. Error codes typically only occur in the rare event of rapid activation, such as re-activating the ESG-400 Electrosurgical Generator within 0.2 seconds after the last activation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus is advising users that if the error occurs, to troubleshoot as per the Instructions for Use (IFU) to continue the procedure, and notify Olympus to obtain a replacement cable. This action has been closed-out on 12/05/2017. |
| Contact Information |
1300 657 699 - Olympus Customer Operations |