FUJIFILM EB-580SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04547410400380), received between Mar 25, 2026 and Sep 18, 2026 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathSep 18, 2026No Display/Image

  It was reported that visualization from EB-580S was lost during a procedure. The procedure treatment was delayed to bleeding in a lung. It took ten minutes to find a different room and to get different scope.Per customer, the patient died a few hours after the incident on 8/27 due to bleeding in the lung. The visualization was lost on reentry of the scope. Patient was intubated prior to start of procedure. The procedure was not completed after replacing the scope. The bleeding being treated was not the result of the device.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 50815166 ↗
• InjurySep 16, 2026Image Display Error/Artifact

  On 08/27/2026, FUJIFILM Healthcare Americas Corporation became aware of an event involving EB-580S. It was reported that visualization was lost during a procedure. The procedure treatment was delayed to bleeding in a lung. It took ten minutes to find a different room and to get different scope. Per customer, the patient died a few hours after the incident on (b)(6) 2026 due to bleeding in the lung. The visualization was lost on reentry of the scope. Patient was intubated prior to start of procedure. The procedure was not completed after replacing the scope. The bleeding being treated was not the result of the device. FUJIFILM Healthcare Americas Corporation is reporting this event, however the cause of death due to existing condition. Ref: FUJIFILM Healthcare Americas Corporation Complaint # (b)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50782620 ↗
• InjuryApr 3, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER WANTS THREE BRONCHOSCOPES EVALUATION TO BE PERFORMED DUE TO PATIENT(S) INFECTION EVENT. THE CUSTOMER CONFIRMED THERE WERE THREE PATIENTS INVOLVED AND POSITIVE CANDIDA WAS CONFIRMED.

  Patient problems: Bacterial Infection

  MAUDE report 24777001 ↗
• InjuryApr 3, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER WANTS THREE BRONCHOSCOPES EVALUATION TO BE PERFORMED DUE TO PATIENT(S) INFECTION EVENT. THE CUSTOMER CONFIRMED THERE WERE THREE PATIENTS INVOLVED AND POSITIVE CANDIDA WAS CONFIRMED.

  Patient problems: Bacterial Infection

  MAUDE report 24777000 ↗
• InjuryApr 3, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER WANTS THREE BRONCHOSCOPES EVALUATION TO BE PERFORMED DUE TO PATIENT(S) INFECTION EVENT. THE CUSTOMER CONFIRMED THERE WERE THREE PATIENTS INVOLVED AND POSITIVE CANDIDA WAS CONFIRMED.

  Patient problems: Bacterial Infection

  MAUDE report 24776999 ↗
• InjuryMar 25, 2026Contamination

  ON 03/02/2026, FUJIFILM HEALTHCARE AMERICAS CORPORTATION BECAME AWARE OF AN EVENT INVOLVING EB-580S. THE CUSTOMER REPORTED A PATIENT INFECTION EVENT. THE PATIENT INFECTION ORGANISM WAS NOT IDENTIFIED. THE CUSTOMER IS UNABLE TO CONFIRM IF THE PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT TO TREAT THE INFECTION. DUE TO THE PATIENT INFECTION, FUJIFILM HEALTHCARE AMERICAS CORPORTATION IS REPORTING THIS EVENT IN AN ABDUNANCE OF CAUTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORTATION COMPLAINT #(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 24692429 ↗
• InjuryMar 25, 2026Contamination

  ON 03/02/2026, FUJIFILM HEALTHCARE AMERICAS CORPORTATION BECAME AWARE OF AN EVENT INVOLVING EB-580S. THE CUSTOMER REPORTED A PATIENT INFECTION EVENT. THE PATIENT INFECTION WAS DUE TO YEAST- CANDIDA ALBICANS. THE CUSTOMER IS UNABLE TO CONFIRM IF THE PATIENT REQUIRED ADDITIONAL MEDICAL ATTENTION TO TREAT THE INFECTION. DUE TO THE PATIENT INFECTION, FUJIFILM HEALTHCARE AMERICAS CORPORTATION IS REPORTING THIS EVENT IN AN ABDUNANCE OF CAUTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORTATION COMPLAINT # (B)(4).

  Patient problems: Fungal Infection

  MAUDE report 24691946 ↗
• InjuryMar 25, 2026Contamination

  ON 03/02/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING EB-580S. THE CUSTOMER REPORTED A PATIENT INFECTION EVENT. THE PATIENT INFECTION WAS DUE TO YEAST - CANDIDA ALBICANS. THE CUSTOMER IS UNABLE TO CONFIRM IF THE PATIENT REQUIRED ADDITIONAL MEDICAL ATTENTION TO TREAT THE IDENTIFIED INFECTION. DUE TO THE PATIENT INFECTION, FUJIFILM HEALTHCARE AMERICAS CORPORTATION IS REPORTING THIS EVENT IN AN ABDUNANCE OF CAUTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

  Patient problems: Fungal Infection

  MAUDE report 24691676 ↗