Device product
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Z-0716-2025
Product summary
- Firm
- Trokamed GmbH
- Event
- Event 95770
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 102 units
- Official record key
device-enforcement:Z-0716-2025
Official wording
Reason: If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Code information: REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
Distribution pattern: US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Derived failure modes
-
Foreign material or chemical contamination
stone fragments