FUJIFILM EG-600WR v2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410337402), received between Jul 24, 2018 and Dec 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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.

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.

• InjuryDec 11, 2025Partial Blockage; Suction Failure; Partial Blockage; Suction Failure

  ON 11/19/2025, FUJIFILM HEALTHCARE AMERICAS CORPORTATION WAS INFORMED OF AN EVENT INVOLVING EG-600WR V2. IT WAS REPORTED THAT THE LOANER SCOPE WAS SENT WITH FAULTY SUCTIONING. THE CUSTOMER HAD POOR SUCTION QUALITY AND INSUFFLATION ABILITIES. THE SCOPE HAD TO BE SWITCHED OUT MID- PROCEDURE. THE PROVIDER INDICATED THIS COULD POTENTIALLY CAUSE HARM TO PATIENTS. DUE TO UNKNOWN THE PATIENT HARM, FUJIFILM HEALTHCARE AMERICAS CORPORTATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. REF COMPLAINT NUMBER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 23784920 ↗
• MalfunctionJul 24, 2018Component or Accessory Incompatibility; Component or Accessory Incompatibility

  A MEDLINE BRUSH (NOT VALIDATED OR RECOMMENDED FOR USE WITH FUJIFILM SCOPES) WAS USED TO CLEAN A FUJIFILM GASTROSCOPE MODEL EG-600WR V2. PART OF THIS BRUSH BROKE DURING THE CLEANING PROCESS. THE CUSTOMER IS NOT CERTAIN IF THE BROKEN BRUSH PART HAD GOTTEN STUCK IN THE SCOPE OR WAS FLUSHED OUT OF THE SCOPE. NO EVIDENCE OF THE BROKEN BRUSH PART WAS FOUND AFTER SUBSEQUENT REPROCESSING CYCLES. THE SCOPE WAS USED ON OTHER PATIENTS, WITH NO REPORTS OF INFECTION. ABOUT A WEEK LATER, THE CUSTOMER INFORMED FUJIFLIM THAT THE BRUSH HAD BEEN FOUND; HOWEVER, THE CUSTOMER REFUSED TO SEND IN THE BRUSH. FUJIFILM WAS INFORMED THAT THE SPECIFIC MEDLINE BRUSH MODEL WAS CURRENTLY BEING RECALLED BY THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714294 ↗