Device product
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Z-2501-2021
Product summary
- Event
- Event 88520
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-2501-2021
Official wording
Reason: As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Code information: Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Distribution pattern: U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Derived failure modes
-
Device software or design
design changes, sheaths have exhibited cracking/breaking