| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01044-1 |
| Product Name/Description |
Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)
Single-Site Bipolar Maryland
Product Code: INS-428080
Single-Site Curved Needle Drive
Product Code: INS-428088
ARTG Number: 132453, 146826 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia (DTA) in conjunction with the manufacturer, Intuitive Surgical Inc, is informing customers that the incorrect version of the user manual associated with the Single-Site instruments, specifically the Bipolar Maryland and Curved Needle Driver instruments, was not distributed to customers prior to shipment and use of the instruments. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is notifying their customers of the issue. A Device Technologies representative will contact each customer to organise the delivery of the correct User Manual. Customers are requested to discard the previous version once the new User Manual has been received. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 429 551 - Device Technologies Customer Care |