Device product
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
Z-0639-2021
Product summary
- Event
- Event 86763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,800 units
- Official record key
device-enforcement:Z-0639-2021
Official wording
Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information: Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097
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