Product Wiki · Recalls · Health Canada — Medical Devices

da Vinci Xi EndoWrist Stapler 45 Reload (2018-04-27) — recall 60950

Health Canada — Medical Devices · Canada · 2018-05-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60950
Date of alert
2018-05-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/da-vinci-xi-endowrist-stapler-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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