EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji 3.2-EPR-EGD-FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854172008155), received between Aug 2, 2023 and Aug 2, 2023 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2022 A 75-YEAR- OLD PATIENT WAS UNDERGOING AN ENDOSCOPIC RESECTION FOR DYSPLASIC BARRETT'S ESOPHAGUS. THE PHYSICIAN RESECTED 100% OF THE CIRCUMFERENCE OF THE LUMEN WITHIN THE TREATABLE SEGMENT. THERE WERE NO ISSUES REPORTED DURING THE PROCEDURE. POST-PROCEDURE, THE PATIENT BEGAN FEELING PAIN AND DEVELOPED SYMPTOMS OF HYPOTHERMIA AND HEMATEMESIS, TWICE. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) PROTON-PUMP INHIBITORS (PPIS) TO TREAT THE SYMPTOMS. THE PATIENT THEN PRESENTED TO THE EMERGENCY UNIT 14 DAYS FROM THE PROCEDURE DATE. AT THE EMERGENCY UNIT, THE PATIENT WAS DIAGNOSED WITH GRADE 3 DYSPHAGIA SYMPTOMS. THE PATIENT WAS RE-HYDRATED AND A FEEDING TUBE VIA PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WAS PLACED. THE PATIENT UNDERWENT AN ENDOSCOPIC DILATION. A NARROW AND VERY SHORT(< 1 CM) STRICTURE WAS OBSERVED WHICH RESOLVED AFTER 7 ESOPHAGEAL ENDOSCOPIC DILATION SESSIONS. IT WAS NOTED THAT THE TIME OF THE INCIDENT, THE PATIENT WAS ENROLLED IN AN ENDOBARRET'S STUDY.

  Patient problems: Dysphagia/ Odynophagia; Hematemesis

  MAUDE report 17442757 ↗