FUJIFILM medwork FROG VAL1-F1-100Recalls & reported problems
FUJIFILM medwork GmbH · 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 04044503035158), received between Apr 17, 2025 and Apr 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
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 24, 2025Defective Device; Defective Device
ON APRIL 15TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED BY FUJIFILM MEDWORK GMBH OF THE REPORTABLE EVENT INVOLVING VAL1-F1-100 FROM THE MANUFACTURER. DURING AN FDA-INSPECTION ON (B)(6) 2025, IT WAS FOUND THAT COMPLAINT INVOLVING THE VAL1-F1-100 WAS NOT EVALUATED FOR REPORTABILITY TO THE FDA. THEREFORE, VAL1-F1-100 COMPLAINT RECEIVED PRIOR TO THE INSPECTION WERE EVALUATED FOR FDA MDR. FUJIFILM MEDWORK GMBH RECEIVED THIS COMPLAINT ON (B)(6) 2025, DETERMINED IT TO BE REPORTABLE (MDR 3020707080-2025-00002 SUBMITTED ON APRIL 16TH, 2025). DURING A COLONOSCOPY THERAPY, USING A PENTAX ENDOSCOPE AND FUJIFILM VAL1-F1-100 VALVE, THE MEMBRASE HAS NOT OPENED DURING THE INTRODUCTION OF A SYRINGE, AND THE INTRODUCTION OF THE ENDOSCOPY IS SOMETIMES REALLY DIFFICULT. IT CREATED A SITUATION OF POTENTIAL SPATTERING SINCE IT DEMANDS TO OPEN THE CORK OF THE VALVE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901627 ↗MalfunctionApr 17, 2025Defective Device; Defective Device
THE MEMBRASE HAS NOT OPENED DURING THE INTRODUCTION OF A SYRINGE ET, THE INTRODUCTION OF THE ENDOSCOPY IS SOMETIMES REALLY DIFFICULT. IT CREATED A SITUATION OF POTENTIAL SPATTERING SINCE IT DEMANDS TO OPEN THE CORK OF THE VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21852964 ↗
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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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