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Recall Observatory FDA recall evidence

Device product

Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex 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-5410

Z-2268-2023

May 15, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92383
Status
Ongoing
Classification
Class II
Quantity
1908.2 units
Official record key
device-enforcement:Z-2268-2023

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: 00815686020637 Lot Number: 06332230201 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

    reason.no_named_rule · v1.0.0

    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