FUJIFILM EB-530USRecalls & reported problems
Fujifilm Corporation · The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547410330182), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EB-530US. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE THE B20BU BALLOON DETACHED FROM THE BRONCHOSCOPE AND WAS FOUND IN THE PATIENT'S AIRWAY, REQUIRING IMMEDIATE INTERVENTION TO REMOVE THE BALLOON. THE BALLOON WAS RETRIEVED WITHOUT PATIENT HARM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT.
Patient problems: Airway Obstruction
MAUDE report 17234780 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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