Device product
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Z-1009-2024
Product summary
- Event
- Event 93792
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
- Official record key
device-enforcement:Z-1009-2024
Official wording
Reason: Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
Code information: UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)
Distribution pattern: Domestic US distribution nationwide.
Derived failure modes
-
Unknown
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.