Home › Scivita Medical Technology Co., Ltd. › Single-use Broncho Videoscope

Single-use Broncho Videoscope

Scivita Medical Technology Co., Ltd. · Model SBV-1A-B · UDI-DI 06971381254679

EOQ Prescription

510(k) clearances

33,128

Adverse events (209 deaths)

160

Recalls

191

Facilities

Description

The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the 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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Data 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.