Device product
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Z-0338-2024
Product summary
- Event
- Event 93222
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-0338-2024
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): LF-DP (04953170136856), LF-GP (04953170061998), LF-TP (04953170317576).
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
contamination that could lead