| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00522-1 |
| Product Name/Description |
Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved Scissors
Part numbers: 420179-09 and -10, 400179-09 and-10 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Certain versions of the MSC instruments may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. The manufacturer identified these micro-cracks during internal testing of an unrelated design modification. These micro-cracks may create a pathway for electrosurgical energy to lead to patient tissue during use and potentially cause thermal injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is requesting their customers to follow work around instructions until alternative stock can be provided. |
| Contact Information |
02 9975 5755 - Device Technologies |