| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00561-1 |
| Product Name/Description |
Procise EZ View with Integrated Cable
(Electrosurgical electrode)
Product No.: EIC8875-01
Lot Number: 1093290
ARTG Number:221504 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew Surgical Pty Ltd. has initiated a recall of Arthrocare Corporation PROCISE EZ View with Integrated Cable Wands, Lot 1093290, due to a manufacturing inspection issue. Affected lot of these devices have been released without meeting the dielectric specifications.
In the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. This created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. Also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. To date there have been no reported adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016. |
| Contact Information |
02 9857 3999 - Smith & Nephew |