FUJIFILM EC-600WL v2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410337396), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 injury, 1 malfunction.

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.

• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JULY 01, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE FOR DIAGNOSTIC PURPOSES A TEAR OCCURRED IN THE PATIENT'S COLON. THIS OCCURRED DURING THE FINAL STAGES OF THE PROCEDURE, THE DOCTOR RETROFLEXED THE SCOPE IN THE COLON WHICH LED TO THE TEAR. THE DOCTOR APPLIED A MEDICAL CLIP TO THE TEAR, WHICH WILL BE EXPELLED WITH THE PATIENT'S BOWEL MOVEMENT WITHIN THE NEXT MONTH ONCE THE TEAR HAS HEALED. THE PATIENT WAS RELEASED FROM THE ENDOSCOPY CENTER AFTER THE PROCEDURE WAS COMPLETED. THE SCOPE WAS TAKEN OUT OF USE AFTER THE PROCEDURE WAS COMPLETED. THE DOCTOR BELIEVED THAT THERE WAS A SHARP EDGE AT THE DISTAL END WHICH LED TO THE TEAR IN THE PATIENT. HOWEVER AFTER FURTHER INSPECTION OF THE COLONOSCOPY SCOPE, WHICH WAS INSPECTED BY THE LEAD ENDOSCOPY TECHNICIAN, THERE WAS NO SIGN OF ANY SHARP EDGES. THE TECHNICIAN DID NOT BELIEVE THAT THIS WAS A USER ERROR; HOWEVER THERE WAS ALSO NO PROOF TO SUGGEST OTHERWISE. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 10307554 ↗
• MalfunctionJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JULY 01, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE FOR DIAGNOSTIC PURPOSES A TEAR OCCURRED IN THE PATIENT'S COLON; FMSU NOTIFIED FUJIFILM CORPORATION OF THE EVENT ON JULY 07, 2020. THIS OCCURRED DURING THE FINAL STAGES OF THE PROCEDURE, THE DOCTOR RETROFLEXED THE SCOPE IN THE COLON WHICH LED TO THE TEAR. THE DOCTOR APPLIED A MEDICAL CLIP TO THE TEAR, WHICH WILL BE EXPELLED WITH THE PATIENT'S BOWEL MOVEMENT WITHIN THE NEXT MONTH ONCE THE TEAR HAS HEALED. THE PATIENT WAS RELEASED FROM THE ENDOSCOPY CENTER AFTER THE PROCEDURE WAS COMPLETED. THE SCOPE WAS TAKEN OUT OF USE AFTER THE PROCEDURE WAS COMPLETED. THE DOCTOR BELIEVED THAT THERE WAS A SHARP EDGE AT THE DISTAL END WHICH LED TO THE TEAR IN THE PATIENT. HOWEVER AFTER FURTHER INSPECTION OF THE COLONOSCOPY SCOPE, WHICH WAS INSPECTED BY THE LEAD ENDOSCOPY TECHNICIAN, THERE WAS NO SIGN OF ANY SHARP EDGES. THE TECHNICIAN DID NOT BELIEVE THAT THIS WAS A USER ERROR; HOWEVER THERE WAS ALSO NO PROOF TO SUGGEST OTHERWISE. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion

  MAUDE report 10307493 ↗