| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00440-1 |
| Product Name/Description |
da Vinci Xi EndoWrist Stapler Release Kit (SRK)
Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release Kit
Product Code: INS-381215
Part Number: 381215-02
ARTG Number: 228401 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Intuitive Surgical has received complaints where the SRK tool has broken during use. It was determined that misinterpretation of instructions provided on the IS4000 SRK instruction card may result in damage of the tool. There have been three clinical cases where the EndoWrist Stapler jaws would not open while clamped on tissue, the SRK tool broke, and the stapler was excised using an alternative stapling device or other surgical intervention. The risk to health due to the SRK tool breakage can range from the minor delay in surgery in order to locate and use a backup SRK or Instrument Release Kit (IRK) tool, to extracting the clamped tissue from the stapler jaws, to the worst case scenario of the clamped tissue needing to be excised using an alternative stapling device or other surgical intervention.
Device Technologies wish to reiterate the proper use of the SRK tool, and to provide additional instructions in the scenario of SRK tool damage. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users in the scenario where the SRK needs to be used, to follow all instructions as provided in the da Vinci Xi EndoWrist Stapler Instruments and Accessories User Manual Addendum and reiterated in the customer letter. If the SRK tool breaks, proceed with the instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and contact your Device Technologies representative to arrange for SRK return through the product complaints process.
This action has been closed-out on 26/03/2018. |
| Contact Information |
07 3623 1400 - Device Technologies |