Device product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Z-0486-2026
Product summary
- Firm
- Covidien, LP
- Event
- Event 97792
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units (OUS only)
- Official record key
device-enforcement:Z-0486-2026
Official wording
Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Code information: CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
Derived failure modes
-
Unknown
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.