| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01240-1 |
| Product Name/Description |
THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)
Multiple Models affected
ARTG Number: 209954 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received complaints of damage to the THUNDERBEAT hand instruments during surgical procedures.
These complaints involve the following or a combination of the following descriptions:
- Cracking and deforming of the THUNDERBEAT probe tip/jaw
- Partial Separation of the PTFE (teflon) Pad
- Exposed Metal Part due to severe wear of the PTFE pad
Probe damage detected during surgery will trigger audible and visual generator alarms. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus Australia is providing additional user instructions on procedural techniques to prevent damage to the Thunderbeat hand instruments. |
| Contact Information |
1300 132 992 - Olympus Australia Customer Service |