Home › NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. › AED 18-35MM Zoom Optical Coupler
AED 18-35MM Zoom Optical Coupler
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model CPLZ 1835 · UDI-DI 00848657070911
FEM
Prescription
4
510(k) clearances
698
Adverse events
5
Recalls
63
Facilities
Description
Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-21 | Ambu Inc. | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device |
| 2019-06-10 | Olympus Corporation of the Americas | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds. |
| 2011-10-28 | Olympus America Inc. | Replacement wheels may break off from the base of the cart |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.