Device product
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Z-2578-2021
Product summary
- Event
- Event 88327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 units
- Official record key
device-enforcement:Z-2578-2021
Official wording
Reason: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Code information: All batch codes
Distribution pattern: US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Derived failure modes
-
Unknown
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery