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Recall Observatory FDA recall evidence

Device product

Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

Z-1458-2024

February 14, 2024

Class II

Product summary

Firm
Covidien, LP
Event
Event 94128
Status
Ongoing
Classification
Class II
Quantity
3,023 units
Official record key
device-enforcement:Z-1458-2024

Official wording

Reason: 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.

Code information: Model Number: SIGSDS30CTVT; UDI/DI: 10884521741888; Lot numbers: N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, N3M1639UY;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.