| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01006-1 |
| Product Name/Description |
da Vinci Xi EndoWrist Stapler
Product Reference: IS4000 EndoWrist Stapler 45
Product Code: INS-470298
ARTG Number: 146826 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
There has been an increase in the number of complaints regarding the “Stapler Firing Failed” message for the Xi Stapler. All cases involving the complaints were completed minimally invasively. One complaint of partial fire resulted in a serious injury when a partial fire across an artery resulted in bleeding (1/12900 Xi staple procedures = 0.01%), which was resolved through use of pressure, suture, and a clip.
The failure message interrupts the Stapler firing prior to completion of the full staple line. When this error occurs, the transection of tissue may be incomplete. In all cases formed staples precede the cut line however; there may be unformed staples at the end of the line. The knife blade could be exposed. While this message can occur with gray, white, blue, or green reloads, the greatest concern is with gray and white reloads, where a partial fire could potentially occur while transecting critical vascular structures such as Pulmonary, Renal or Splenic Vessels. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that In the event of the “Stapler Firing Failed” message, please note the following:
1. While the Stapler remains in the clamped state, it provides compression and tamponades the vasculature.
2. Surgeons should ensure hemostatic and leak control, particularly when around critical vessels with the gray or white reload, before releasing the Stapler from the structure.
3. After unclamping, a blade may be exposed; hence, surgeons should not manipulate tissue with the Stapler after the “Stapler Firing Failed” message occurs.
4. Bedside assistants should take care when removing the fired reload, as sharps hazards, such as potentially exposed knife and unformed staples, may be present.
A software correction has been completed as a permanent correction. This action has been closed-out on 03/02/2017. |
| Contact Information |
1300 338 423 - Device Technologies |