FDA-Device2024-04-10Class II
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP
Hazard
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Sold states
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Affected count
30 Units
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2024Don't want to check this manually?
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