| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00854-1 |
| Product Name/Description |
E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)
Catalogue: MG0100LS
Lot Numbers: 131509, 131946
ARTG Number: 192262 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The distal portion of the electrode insulation of a small number of units may have been damaged during manufacture. In the event that a unit with damaged insulation is used on a patient contrary to recommended instructions for use supplied with the product, thermal damage could occur to the patient’s peripheral tissue. Such damage would be outside the surgeon’s primary field of view during a laparoscopic procedure and therefore not easily identified at the time of occurrence. . |
| Recall Action |
Recall |
| Recall Action Instructions |
Big Green Surgical is requesting users to quarantine all affected units. Affected stock will be replaced by Big Green Surgical or a credit note issued. |
| Contact Information |
1300 244 473 - Big Green Surgical Customer Service |