Device product
ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
Z-0649-2021
Product summary
- Event
- Event 86763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,000 units
- Official record key
device-enforcement:Z-0649-2021
Official wording
Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information: Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640
Distribution pattern: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Derived failure modes
-
Unknown
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure