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EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP. · Model OLYMPUS BF TYPE UC180F · UDI-DI 04953170355608
4
510(k) clearances
6,336
Adverse events (7 deaths)
2
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-07-27 | Olympus Corporation of the Americas | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
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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.