| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00520-1 |
| Product Name/Description |
Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Systems
Affected Products:
INS-428061 5 X 300MM CURVED CANNULA ARM 1
INS-428062 5 X 300MM CURVED CANNULA ARM 2
INS-428071 5 X 250MM CURVED CANNULA ARM 1
INS-428072 5 X 250MM CURVED CANNULA ARM 2
ARTG Number: 97289 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia (DTA) in conjunction with the manufacturer, Intuitive Surgical Inc., is issuing this Recall for Product Correction for 5mm Curved Cannula for Single-Site Instruments, to update the User Manual. As indicated in the User Manual Addendum, cannula damage can include cracks in the tube or bowl/tube interface and tube wall anomalies etc and may result from incorrect placement of the cannulae. If cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue and generate excessive forces on the patient body wall. This contact may cause tissue injury and require additional surgical and/or medical intervention. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The “Single-Site Cannula Inspection and Use – Single-Site User Manual Addendum” will be
hand delivered to the Nurse Unit Manager by your Product Specialist. |
| Contact Information |
1800 429 551 - Device Technologies |