| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00142-1 |
| Product Name/Description |
Diego Elite Tubeset, Standard and Declog
(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)
Item Codes: TS100S and TS101DC
Multiple Lot Numbers
ARTG Number: 143268 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
A problem has identified a problem with the Diego Elite Tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. If the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. At this stage, no reports of injuries relating to the drive shaft disengagement have been received. |
| Recall Action |
Recall |
| Recall Action Instructions |
Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or replacement stock.
This action has been closed out on 7/09/2018. |
| Contact Information |
03 9265 5591 - Olympus Australia |