Device product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382
Z-2265-2023
Product summary
- Event
- Event 92383
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 526.4 units
- Official record key
device-enforcement:Z-2265-2023
Official wording
Reason: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
Code information: UDI-DI: 00815686020590 Lot Numbers: 04992210324 and below
Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
Derived failure modes
-
Unknown
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay