Device product
THORACIC ROBOTS, DYNJ908777B
Z-1707-2026
Product summary
- Event
- Event 98530
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,379 kits total
- Official record key
device-enforcement:Z-1707-2026
Official wording
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Code information: UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Derived failure modes
-
Foreign material or chemical contamination
foreign body