| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00326-1 |
| Product Name/Description |
Classic Series Reusable Active Cord
Designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators
Model Number: C650-129A
All Serial Numbers
ARTG Number:137430
(Olympus Australia - Cable/lead, electrosurgical unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Olympus has been made aware by the manufacturer, Gyrus ACMI, of an issue with the C650-129A Classic Series Reusable Cord whereby the cord may become damaged and potentially trigger sparks during use. In the event that cord is damaged, it may short circuit and pose risk of minor electrical shock/burn to the user or patient. If the shorting cable comes in to contact with flammable material there is a risk of fire in the operating room.
Investigation of this issue revealed that due to the configuration and location of the cable, the problem could result from users pulling on the cable as opposed to the connector when unplugging the cable. Olympus recommends that cables are unplugged by grasping the plug and not by pulling on the cable.
To date, there have been no reports of patient injury or death as a result of this issue.
Olympus Australia has ceased supply of the C650-129A Classic Series Reusable Active Cord since November 2013. |
| Recall Action |
Recall |
| Recall Action Instructions |
Olympus is advising users to inspect inventory for any C650-129A Classic Series Reusable Active Cords, cease use and dispose of them accordingly.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1300 657 699 - Olympus Customer Operations |