| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00583-2 |
| Product Name/Description |
Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)
5mm Cannula
Product code: INS-420011
5mm Flared Cannula
Product code: INS-420262
ARTG Number: 97289 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received a small number of customer complaints regarding damaged 5mm cannula which could lead to difficulty inserting or utilising 5mm surgical instruments. Using a damaged or bent cannula can result in the loss of smooth instrument motion and/or particles of instrument shaft material being generated, which may drop into the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is updating the current instructions for use with a modified inspection process for the identification of damaged or bent cannula using an obturator which will be provided to users. |
| Contact Information |
02 9975 5755 - Device Technologies |