da Vinci Xi EndoWrist Stapler 45 Reload (2018-04-27)
- Starting date:
- April 27, 2018
- Posting date:
- May 18, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66806
Affected products
da Vinci Xi EndoWrist Stapler 45 Reload
Reason
Specific lots of the da Vinci Xi Stapler 45 Blue and Green Reloads may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired. As a result, the user may see a staple line that has all the staples formed, but no tissue transection. The only manner by which a user will be made aware of the issue is through visual inspection of the tissue after using the stapler.
Affected products
da Vinci Xi EndoWrist Stapler 45 Reload
Lot or serial number
M10161214
Model or catalog number
48445G
48645B
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
UNITED STATES