Device product
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Z-2350-2024
Product summary
- Event
- Event 94827
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 256 US, 39 OUS
- Official record key
device-enforcement:Z-2350-2024
Official wording
Reason: Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
Code information: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Distribution pattern: Domestic distribution nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign material