FUJIFILM EC-600HLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410330212), received between Aug 8, 2018 and Sep 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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.

• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOMETHING APPEARS TO BE LODGED IN THE FORWARD WATER JET OF THE ENDOSCOPE FORCING A BIFURCATED STREAM OF WATER INSTEAD OF ONE CONTINUAL STREAM. THIS CAUSED THE PRESSURE TO BE INCREASED CAUSING A MUCOSAL ABRASION IN THE RIGHT PART OF THE COLON. DOCTOR WAS UNSURE IF THE BIFURCATED STREAM WAS APPARENT PRIOR TO THE CASE, OR HAPPENED INTERPROCEDURALLY. IF PRIOR TO THE CASE, THEN THIS COULD BE A CROSS CONTAMINATION ISSUE. DURING AN INTERNAL REVIEW, IT WAS IDENTIFIED THAT THIS EVENT WAS NOT REPORTED TO FDA BY THE IMPORTER AS REQUIRED BY 21 CFR 803. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 07/26/2018. THE MANUFACTURER REPORTED THIS EVENT TO FDA UNDER REPORT # 3001722928-2018-00057.

  Patient problems: Abrasion

  MAUDE report 12445787 ↗
• MalfunctionAug 8, 2018Device Reprocessing Problem; Device Reprocessing Problem

  SOMETHING APPEARS TO BE LODGED IN THE FORWARD WATER JET OF THE ENDOSCOPE FORCING A BIFURCATED STREAM OF WATER INSTEAD OF ONE CONTINUAL STREAM. DOCTOR WAS UNSURE IF THE BIFURCATED STREAM WAS APPARENT PRIOR TO THE CASE, OR HAPPENED INTRAPROCEDURAL. IF PRIOR TO THE CASE, THEN THIS COULD BE A CROSS CONTAMINATION ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762697 ↗