| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00222-1 |
| Product Name/Description |
da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer
da Vinci Si EndoWrist One Vessel Sealer
Product Code: 410322-05; Order code INS-410322
Multiple Lot Numbers
da Vinci Xi EndoWrist Vessel Sealer
Product Code: 480322-04; Order Code INS-180322
Multiple Lot Numbers
ARTG Number: 132453 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the proximal end (near the joint) of the instrument grips. This interference is due to manufacturing variability in some jaws. The interference can lead to contact between the instrument electrodes at the back of the jaws and subsequent shorting of the electrosurgical energy. The shorting behaviour can lead to extended activation times and insufficient energy delivery to thin, vascular tissue bundles, leading to bleeding if transected. This issue has been identified on a small population of Vessel Sealers only when used on thin, vascular tissue. There has been no impact identified to sealing performance on larger vessels or tissue bundles. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia (DTA) is informing the customers of the potential for insufficient energy delivery on a small population of Vessel Sealers only when used on thin, vascular tissue and providing instructions on alternative methods of sealing and transection. In caseWhere the customer does not wish to use affected Vessel Sealer instruments, DTA is offering a full credit refund for affected stock in its original packaging. This action has been closed-out on 08/08/2016. |
| Contact Information |
07 3623 1400 - Device Technologies |