FUJIFILM medwork VAL1-G7-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04044503055828), received between Apr 17, 2025 and Apr 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Defective Device; Defective Device

  ON (B)(6) 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED BY FUJIFILM MEDWORK GMBH OF THE REPORTABLE EVENT INVOLVING VAL1-G7-50 FROM THE MANUFACTURER. DURING AN FDA-INSPECTION ON (B)(6) 2025, IT WAS FOUND THAT COMPLAINT INVOLVING THE VAL1-G7-50 WAS NOT EVALUATED FOR REPORTABILITY TO THE FDA. THEREFORE, VAL1-G7-50 COMPLAINT RECEIVED PRIOR TO THE INSPECTION WAS EVALUATED FOR FDA MDR. FUJIFILM MEDWORK GMBH RECEIVED THIS COMPLAINT ON (B)(6) 2022, AND ON (B)(6) 2025, DETERMINED IT TO BE REPORTABLE (MDR 3020707080-2025-00003 SUBMITTED ON (B)(6) 2025). THE PROBLEM ONLY OCCURRED WITH THE LAST BATCH DELIVERED OF FUJIFILM VALVES VAL1-G7-50, QTY - 10, USED WITH FUJIFILM ENDOSCOPE, WHERE NO PRODUCTS CAN BE PUSHED THROUGH THE OPENING WITHOUT PERFORATING THE FROG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885897 ↗
• MalfunctionApr 22, 2025Defective Device; Defective Device

  ON APRIL 15TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED BY FUJIFILM MEDWORK GMBH OF THE REPORTABLE EVENT INVOLVING VAL1-G7-50 FROM THE MANUFACTURER. DURING AN FDA-INSPECTION ON MARCH 25TH, 2025, IT WAS FOUND THAT COMPLAINT INVOLVING THE VAL1-G7-50 WAS NOT EVALUATED FOR REPORTABILITY TO THE FDA. THEREFORE, VAL1-G7-50 COMPLAINT RECEIVED PRIOR TO THE INSPECTION WAS EVALUATED FOR FDA MDR. FUJIFILM MEDWORK GMBH RECEIVED THIS COMPLAINT ON JUNE 22ND, 2022, AND ON MARCH 27TH, 2025, DETERMINED IT TO BE REPORTABLE (MDR 3020707080-2025-00004 SUBMITTED ON APRIL 16TH, 2025). DURING A COLONOSCOPY THERAPY AND GASTROSCOPY DIAGNOSIS PROCEDURE, USING A FUJIFILM ENDOSCOPE, THE FUJIFILM VAL1-G7-50 VALVE WAS FOUND TO BE LEAKING. THE LEAKING BIOPSY VALVE MADE IT DIFFICULT TO ENTER INSTRUMENTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885757 ↗
• MalfunctionApr 17, 2025Defective Device; Defective Device

  LEAKING BIOPSY VALVE: DIFFICULT TO ENTER INSTRUMENTS AS WELL THEREFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853225 ↗
• MalfunctionApr 17, 2025Defective Device; Defective Device

  NO PRODUCTS CAN BE PUSHED THROUGH THE OPENING WITHOUT PERFORATING THE FROG. THIS PROBLEM ONLY OCCURRED WITH THE LAST BATCH THAT WAS DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853135 ↗