Device product
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Z-1457-2024
Product summary
- Firm
- Covidien, LP
- Event
- Event 94128
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 Units
- Official record key
device-enforcement:Z-1457-2024
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: 10884521741881; Lot number: N3L1909UY;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Derived failure modes
-
Unknown
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.