FUJIFILM EC-600LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410330229), received between Nov 15, 2023 and Dec 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 25, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE SCOPE WAS SWABBED FOR STANDARD MICRO TESTING ON 10/28/2025. CULTURE RETURNED POSITIVE 10/31/2025. SCOPE WAS REPROCESSED USING AER ON 10/31/2025 AND REMOVED FROM SERVICE. THE SCOPE WAS CULTURE TESTED AS PART OF THEIR MONTHLY TESTING STANCE, AND IT FAILED. THEY PUT IT IN THE AER AGAIN AND CULTURE TESTED AGAIN, THIS TIME IT PASSED. THE SCOPE WAS SENT IN FOR EVALUATION. THE AREA THAT FAILED THE INITIAL TEST WAS THE DISTAL TIP. THE FACILITY STAFF (REGISTERED NURSE) CONFIRMED THE SCOPE IN QUESTION WAS LAST USED ON A PATIENT (B)(6) 2025. NO MALFUNCTION OCCURRED WHEN THE SCOPE IN QUESTION WAS USED ON A PATIENT. THE SCOPE WAS CULTURE TESTED ON 9/30/2025 AND THE RESULTS WERE NEGATIVE. THE SCOPE WAS SWABBED FOR STANDARD MICRO TESTING ON 10/28/2025. CULTURE RETURNED POSITIVE 10/31/2025. THE SCOPE WAS RE-CULTURED ON 10/31/2025 AND 11/3/2025 WITH NEGATIVE RESULTS. AFTER THE SCOPE WAS MANUALLY CLEANED THROUGH THEIR AER UNIT AND PLACED IN STORAGE, THERE WERE NO ISSUES FOUND AFTER THE CLEANING PROCESS. CUSTOMER HAS NOT CONFIRMED THE POSITIVE CULTURE ORGANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891915 ↗
• MalfunctionNov 15, 2023Break; Break

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING WITH EC-600LS. IT WAS REPORTED THAT THE KNOB BROKE DURING THE PROCEDURE PRIOR TO REACHING CECUM AND THE KNOB WAS UNABLE TO ROTATE. THERE WAS A DELAY TO SWITCH TO A DIFFERENT SCOPE. THERE WAS NO INJURY TO THE PATIENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139948 ↗