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Zhuhai Wesee Meditech Co., Ltd. · Model SP11A · UDI-DI 06976712910477
EOB
Prescription
1
510(k) clearances
7,689
Adverse events (1 deaths)
8
Recalls
132
Facilities
Description
The Disposable Video Rhinolaryngoscope SP11A is sterile,single-use, flexible endoscope intened for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
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.