FUJIFILM EG-580UTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547410349061), received between Jul 6, 2023 and Oct 8, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THERE WAS A LEAK AT THE BIFURCATION OF VIDEO/US CONNECTOR. ALSO REPORTED A FAILED CULTURE PROCESS WITH POSITIVE FINDING AT THE ELEVATOR AND A SECOND FINDING (ALSO AT ELEVATOR) FOLLOWING THE SUBSEQUENT REPROCESSING. CUSTOMER REQUESTED SERVICE TO PERFORM A FULL PRODUCT MAINTENANCE WITH THIS IN MIND. THERE WAS NO PATIENT INVOLVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED REGARDING THE RESULTS OF THE CULTURE TESTS. ON (B)(6) 2024, THE SCOPE WAS CULTURED. RESULTS FROM THE CULTURE GREW CANDIDA ALBICANS. ON (B)(6) 2024 THE SCOPE WAS RE-CULTURED. POSITIVE CULTURE GREW KLEBSIELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394591 ↗
• MalfunctionDec 5, 2023Contamination; Contamination

  ON (B)(6) 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT THERE IS AN ISSUE OCCURRED WITH THE ELEVATOR MECHANISM. IN ADDITIONAL, THE SCOPE FAILED BOTH ATP AND CULTURING. ON (B)(6) 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING THE SAME EG-580UT. IT WAS REPORTED THAT THE SCOPE FAILED CULTURING MULTIPLE TIMES. THERE IS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THE EVENT. THIS REPORT IS BEING SUBMITTED DUE TO POTENTIAL OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271829 ↗
• MalfunctionDec 4, 2023Microbial Contamination of Device; Microbial Contamination of Device

  ON NOVEMBER 8TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT THE SCOPE FAILED CULTURING MULTIPLE TIMES. THERE IS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED DUE TO POTENTIAL OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256858 ↗
• MalfunctionNov 13, 2023Microbial Contamination of Device; Microbial Contamination of Device

  ON OCTOBER 17TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT THERE IS AN ISSUE OCCURRED WITH THE ELEVATOR MECHANISM. IN ADDITIONAL, THE SCOPE FAILED BOTH ATP AND CULTURING. THERE IS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED DUE TO POTENTIAL OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120769 ↗
• MalfunctionJul 13, 2023Residue After Decontamination; Contamination /Decontamination Problem; Residue After Decontamination; Contamination /Decontamination Problem

  ON JUNE 13, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT DURING PREPARATION A RED LIQUID WAS OBSERVED ON THE BALLOON ATTACHED TO THE DISTAL END OF THE SCOPE. THE SCOPE WAS WASHED TWICE WITH AER, BUT THE RED LIQUID FLOWED OUT OF THE NOZZLE, AND USE OF THE SCOPE WAS DISCONTINUED. THERE IS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316100 ↗
• MalfunctionJul 6, 2023Residue After Decontamination; Contamination /Decontamination Problem; Residue After Decontamination; Contamination /Decontamination Problem

  ON JUNE 8, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT DURING PREPARATION A RED LIQUID WAS OBSERVED ON THE BALLOON ATTACHED TO THE DISTAL END OF THE SCOPE. THE SCOPE WAS WASHED TWICE WITH AER, BUT THE RED LIQUID FLOWED OUT OF THE NOZZLE, AND USE OF THE SCOPE WAS DISCONTINUED. THERE IS NO PATIENT INVOLVEMENT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274415 ↗