FUJIFILM EB-580TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547410400397), received between Sep 6, 2023 and Apr 15, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Break

  THE TIP OF THE BRONCHOSCOPE CAME OFF AND FELL INTO THE PATIENT'S AIRWAY. THE PROCEDURE WAS COMPLETED AFTER SWITCHING OUT THE SCOPES. THERE WAS A 10-MINUTE DELAY TO REMOVE THE PIECE THAT FELL OFF AND TO SWITCH THE SCOPES. NO DELAYS THEREAFTER TO COMPLETE THE PROCEDURE.THE PATIENT DID NOT EXPERIENCE ANY HARM, INJURY, OR COMPLICATIONS AFTER THE PROCEDURE. NO ADDITIONAL TREATMENT OR MONITORING WAS REQUIRED. THE PATIENT RECOVERED AND WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882020 ↗
• InjuryMar 20, 2026Detachment of Device or Device Component

  ON 02/24/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING EB-580T. IT WAS REPORTED THAT THE TIP OF THE BRONCHOSCOPE CAME OFF AND FELL INTO THE PATIENT'S AIRWAY. CUSTOMER WAS UNABLE TO USE THE SCOPE. CUSTOMER HAD TO RETRIEVE THE DISTAL TIP OUT OF THE AIRWAY OF THE PATIENT THEN SWITCH SCOPES. THE PATIENT HAS RECOVERED AND WAS DISCHARGED HOME. NO ADDITIONAL TREATMENT OR MONITORING WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY HARM, INJURY, OR COMPLICATIONS AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER SWITCHING THE SCOPE. THERE WAS A 10-MINUTE DELAY TO REMOVE THE PIECE OF THE SCOPE THAT FELL OFF AND SWITCH THE SCOPES. THE PATIENT REMAINED UNDER ANESTHESIA DURING THE DELAY. THE DELAY DID NOT IMPACT THE PATIENT OR PROCEDURE. DUE TO A PIECE OF THE DEVICE FALLING INTO THE PATIENT'S CAVITY, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABDUNANCE OF CAUTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651042 ↗
• MalfunctionMar 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2024, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EB-580T. IT WAS REPORTED THAT THERE IS A CONCERN FOR POTENTIAL DEFECT INSIDE THE SCOPE THAT COULD BE A SOURCE FOR HARBORING BACTERIA. THREE PATIENTS TEST POSITIVE WITH A RARE BACTERIUM AND ARE TRYING TO IDENTIFY A SOURCE.

  Patient problems: Bacterial Infection

  MAUDE report 18861833 ↗
• MalfunctionSep 7, 2023Stretched; Stretched

  ON (B)(6) 2023, FUJIFILM CORPORATION WAS RECEIVED ADDITIONAL INFORMATION OF AN EVENT INVOLVING EB-580T. PRIOR TO THE ADDITIONAL INFORMATION, FUJIFILM CORPORATION DETERMINED THE INCIDENT NON-REPORTABLE. IT WAS REPORTED THAT DURING PROCEDURE USING A COMBINATION OF A BRONCHOSCOPE EB-580T AND AN ENDOTRACHEAL TUBE AT THE FACILITY, WHEN THE EB-580T WAS WITHDRAWN THROUGH THE ENDOTRACHEAL TUBE, THE EB-580T WAS DIFFICULT TO WITHDRAW DUE TO THE BENDING RUBBER MIGRATING TO THE DISTAL END. THE EB-580T WAS REMOVED ALONG WITH THE ENDOTRACHEAL TUBE AND REPLACED WITH ANOTHER SCOPE, AND THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY. THE PATIENT HAS NOT COMPLAINED OF ANY HEALTH HAZARDS. THERE IS NO SERIOUS INJURY AND DEATH OCCURRED ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699327 ↗
• MalfunctionSep 6, 2023Stretched; Stretched

  ON AUGUST,17, 2023, FUJIFILM CORPORATION WAS RECEIVED ADDITIONAL INFORMATION OF AN EVENT INVOLVING EB-580T. PRIOR TO THE ADDITIONAL INFORMATION, FUJIFILM CORPORATION DETERMINED THE INCIDENT NON-REPORTABLE. IT WAS REPORTED THAT DURING PROCEDURE USING A COMBINATION OF A BRONCHOSCOPE EB-580T AND AN ENDOTRACHEAL TUBE AT THE FACILITY, WHEN THE EB-580T WAS WITHDRAWN THROUGH THE ENDOTRACHEAL TUBE, THE EB-580T WAS DIFFICULT TO WITHDRAW DUE TO THE BENDING RUBBER MIGRATING TO THE DISTAL END. THE EB-580T WAS REMOVED ALONG WITH THE ENDOTRACHEAL TUBE AND REPLACED WITH ANOTHER SCOPE, AND THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY. THE PATIENT HAS NOT COMPLAINED OF ANY HEALTH HAZARDS. THERE IS NO SERIOUS INJURY AND DEATH OCCURRED ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691248 ↗