Device product
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Z-0905-2025
Product summary
- Event
- Event 95898
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 30,140 units
- Official record key
device-enforcement:Z-0905-2025
Official wording
Reason: Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Code information: Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.