Device product
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Z-0330-2024
Product summary
- Event
- Event 93222
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0330-2024
Official wording
Reason: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Code information: Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
contamination that could lead