Device product
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
Z-2148-2019
Product summary
- Event
- Event 82519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310000
- Official record key
device-enforcement:Z-2148-2019
Official wording
Reason: There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Code information: Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H
Distribution pattern: The products were distributed US Nationwide.
Derived failure modes
-
Unknown
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.