| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01197-1 |
| Product Name/Description |
Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)
Multiple Lot Numbers affected
ARTG Number: 178675 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
This recall is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument's articulating lever disengaging during use. If the instrument fails to fire or partially fires, or if the articulating lever disengages, there is a potential for minor bleeding should partial fire occur on vasculature and extended procedure time if an alternate device is not readily available. There is a rare potential for conversion from a laparoscopic procedure to an open procedure if the hospital does not have another functioning device from the sponsor or from another vendor. No patient injuries related to these issues have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected units prior to their return.
This action has been closed-out on 5/12/2016. |
| Contact Information |
02 9429 3196- Covidien |