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Sinuscope
SOPRO-COMEG GmbH · Model 161 401 813BC001 · UDI-DI 04059082003207
1
510(k) clearances
7,689
Adverse events (1 deaths)
8
Recalls
132
Facilities
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.