Device product
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
Z-1616-2023
Product summary
- Event
- Event 92129
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1297 (Boxes; 5 per Box)
- Official record key
device-enforcement:Z-1616-2023
Official wording
Reason: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Code information: UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937
Distribution pattern: Natiowide Foreign: Canada, Germany
Derived failure modes
-
Unknown
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.