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Peregrine drivable ENT scope
3NT MEDICAL LTD · Model SWY-0100 · UDI-DI 07290016539073
EOB
Prescription
1
510(k) clearances
8,125
Adverse events (1 deaths)
8
Recalls
132
Facilities
Description
The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-03 | Olympus Corporation of the Americas | Potential for distal end of the sheath to break off during a procedure. |
| 2024-01-16 | Olympus Corporation of the Americas | Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consisten |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2020-05-05 | Olympus Corporation of the Americas | Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
| 2011-12-27 | Vision-Sciences, Inc. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being c |
| 2011-12-27 | Vision-Sciences, Inc. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being c |
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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.