FUJIFILM EC-760S-V/LRecalls & reported problems
Fujifilm Corporation · This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410397642), received between Jun 26, 2024 and Jul 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
- Material Protrusion/Extrusion1
- Material Separation1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Break; Crack; Peeled/Delaminated; Material Separation; Material Protrusion/Extrusion; Break; Crack; Peeled/Delaminated; Material Separation; Material Protrusion/Extrusion
ON JUNE 5TH, 2025 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760S-V/L. IT WAS REPORTED THAT THE SHIFTED CHANNEL WOULD NOT ALLOW A BIOPSY FORCEP TO ADVANCE PAST THE PROBLEM AREA DURING A CASE, RESULTING IN A DELAY. HAD TO WITHDRAW THE BROKEN SCOPE AND USE ANOTHER SCOPE TO RETURN TO THE AREA THAT NEEDED BIOPSY'S THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION DUE TO THE UNCONFIRMED PATIENT IMPACT BY SWITCHING SCOPES TO COMPLETE THE BIOPSY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22386707 ↗MalfunctionJun 26, 2024Break; Break
ON MAY 28TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760S-V/L. IT WAS REPORTED THAT THE DISTAL PORTION OF SCOPE CAME COMPLETELY APART AT THE BENDING SECTION DURING A PROCEDURE. THE STAFF DENY ANY MISHANDLING AND STATE IT HAPPENED WHEN REGULARLY USING AND TURNING THE KNOBS DURING A PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19618045 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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