Health product recall

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