| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01111-1 |
| Product Name/Description |
da Vinci Xi EndoWrist Stapler 45 Instrument
Product Reference: IS4000 EndoWrist Stapler 45
Product Code: INS-470298
Multiple Lot Numbers affected
ARTG Number: 146826 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
There has been a field failure overseas with the da Vinci Xi EndoWrist Stapler 45 Instrument, where the stapler remained clamped on tissue even when the Stapler Release Kit was used. Intuitive Surgical has determined that this issue is the result of a bearing failure within the housing of the instrument. The bearing failure is associated with components from a specific bearing supplier and, as such, is found only in certain lots of instruments.
If the instrument cannot be released from tissue during a procedure, then the stapler and the tissue it is grasping may need to be excised using an alternative stapling device or other surgical intervention. Failure of the bearing may also cause an interruption in shaft rotation, resulting in minimal delay in the surgery while the instrument is examined and replaced with a new one. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is advising users to inspect their inventory and isolate any affected Endowrist Stapler 45 Instruments. Upon receiving notice of affected stock, Device Technologies will arrange for return of the instruments and provide replacement instruments. Opened Endowrist Stapler 45 Instruments are to be cleaned and sterilised before returning. This action has been closed-out on 11/05/2017. |
| Contact Information |
07 3623 1400 - Device Technologies |