FUJIFILM EC-760P-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 04547410368871), received between Oct 25, 2023 and Apr 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Entrapment of Device1
- Insufficient Device Problem Information1
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.
MalfunctionApr 22, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove
ON (B)(6) 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760P-V/L. IT WAS REPORTED THAT DURING THE COLONOSCOPY DIAGNOSTIC PROCEDURE, IT APPEARED TO HAVE RETROFLEX UNINTENTIONALLY IN THE SIGMOID COLON, WHICH WAS NOT ALLOWING THE PROCEDURE TO BE COMPLETED. COLONOSCOPY WAS NOT COMPLETED. POTENTIAL SIGMOID COLON MUCOSAL BRUISE. DURING A COLONOSCOPY, THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE SCOPE DUE TO MULTIPLE DIVERTICULA AND ABORTED THE PROCEDURE; WHILE RETRACTING, THE SCOPE BECAME STUCK BUT IT WAS RELEASED AFTER PATIENT REPOSITIONING AND A DIGITAL EXAM, WHICH MIGHT POTENTIALLY RESULT IN MINOR BRUISE. HOWEVER, THERE WAS NO ADVERSE EVENTS. THE PATIENT REMAINED STABLE, WAS DISCHARGED, AND FOLLOW-UP CONFIRMED FULL RECOVERY. THE INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION AS THE MALFUNCTION COULD CAUSE CONTRIBUTE TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885557 ↗MalfunctionOct 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ON SEPTEMBER 25TH 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-760P-V/L. IT WAS REPORTED THAT DURING A DIAGNOSTIC FOR COLON PROCEDURE THERE WAS NO PERIPHERAL VISION AND DECREASE LIGHTING. THEIR PROCEDURE TOOK LONGER TO FINISH. DUE TO UNKNOWN STATUS OF PATIENT AND EQUIPMENT, THE REPORT IS SUBMITTED WITH ABUNDANCE OF CAUTION. THERE WAS NO INJURY TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003172 ↗
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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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