Home › Scivita Medical Technology Co., Ltd. › Single-use Broncho Videoscope
Single-use Broncho Videoscope
Scivita Medical Technology Co., Ltd. · Model SBV-1C-P · UDI-DI 06971381252385
EOQ
Prescription
1
510(k) clearances
32,212
Adverse events (207 deaths)
160
Recalls
192
Facilities
Description
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section.This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-29 | Olympus Corporation of the Americas | Potential for rubber fragment detachment during use. |
| 2026-01-29 | Olympus Corporation of the Americas | Potential for rubber fragment detachment during use. |
| 2026-01-21 | Auris Health, Inc | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application w |
| 2025-12-04 | Intuitive Surgical, Inc. | Due to probe bags that may have a compromised or incomplete sterile pouch seal. |
| 2025-09-12 | Noah Medical Corporation | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
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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.