| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00351-1 |
| Product Name/Description |
Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S Systems
Multiple product numbers and lot numbers
ARTG numbers: 179469, 150916, and 98557 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
There have been two issues identified with the da Vinci surgical system drapes:
1. The adhesive labels intended to keep the drape folded were found in some instances to be unintentionally overlapping multiple folds of the drape. This issue has the potential to cause small tears when the drape unfolds during the draping process that may lead to possible contamination of the surgical field. There is a slight increased risk for infection, primarily with surface contaminants, that could increase the chance of post-operative wound infection.
2. Some of the drapes used with the da Vinci Systems may exhibit a cloudy/waxy appearance. The cloudy appearance is due to increased presence of anti-static additive in the drape film. Direct exposure to the waxy substance may cause skin irritation and sensitisation. The reaction is minor and limited to immediate contact area with no long-term health consequences. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised that the decision to discontinue use of the potentially affected drapes should be made on a case by case basis. Currently, there is no unaffected stock available for replacement. Prior to use, users are advised to assess drapes per the inspection instructions attached with the customer letter. This inspection is not required for drapes manufactured after 06 March 2015. This correlates to lot numbers greater than 066 as seen in the following format: D15066xx or DA15066xx. Device Technologies’ Product Specialists will provide training to customers with the inspection process. If users identify affected drapes during the inspection, please contact Device Technologies to arrange for returning the affected drapes. This action has been closed-out on 26/02/2016 |
| Contact Information |
1300 338 423 - Device Technologies Australia |