Device product
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Z-0340-2024
Product summary
- Event
- Event 93222
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-0340-2024
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 Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147).
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
contamination that could lead