| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00500-1 |
| Product Name/Description |
da Vinci Xi EndoWrist Stapler Release Kit (SRK)
Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release Kit
Obsolete Product Code: INS-381215
New Product Code: INS-381215-03
Part Number: 381215-02
ARTG Number: 228401
(Device Technologies Australia - Wrench, surgical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
In March 2017, Device Technologies Australia (DTA) in conjunction with Intuitive Surgical sent correspondence (TGA ref RC-2017-RN-00440-1) highlighting the proper use of the da Vinci Xi EndoWrist Stapler Release Kit (SRK) tool and providing additional information regarding the use of the Instrument Release Kit (IRK) tool as a backup if a SRK tool was not available.
Further to this, Intuitive Surgical has now developed an improved da Vinci Xi EndoWrist Stapler Release Kit (SRK) tool, which reduces the likelihood of breakage. Please note that the Instructions For Use (IFU) remain the same. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process.
Users are reminded to refer to the IFU for appropriate use of the device.
This action has been closed out on 12/02/2019 |
| Contact Information |
07 3623 1400 - Device Technologies |