Device product
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Z-1489-2026
Product summary
- Event
- Event 98240
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,276 boxes (20 units per box)
- Official record key
device-enforcement:Z-1489-2026
Official wording
Reason: Potential for rubber fragment detachment during use.
Code information: Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
rubber fragment