Device product
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
Z-0642-2021
Product summary
- Event
- Event 86763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,000
- Official record key
device-enforcement:Z-0642-2021
Official wording
Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information: Lot Numbers: 19121826 Unit UDI: 04897106951178 Box UDI: 14897106951175 Cartoon Box UDI: 24897106951172
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