DUODENOVIDEOSCOPE TJF-150 (UDI 04953170229459)Recalls & reported problems

Summary

The FDA's MAUDE database contains 413 adverse event reports that list this exact device (DI 04953170229459), received between Apr 18, 2019 and Sep 16, 2026 — classified as 4 deaths, 5 injuries, 404 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (194 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 25 most recent of 413 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Contamination /Decontamination Problem

  During onsite inspection of a Duodenovideoscope, it was found the k-wire has foreign objects. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793109 ↗
• MalfunctionAug 13, 2026Pitted; Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239285 ↗
• MalfunctionAug 6, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155986 ↗
• MalfunctionJul 21, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894518 ↗
• MalfunctionJun 11, 2026Residue After Decontamination

  THE CUSTOMER RETURNED THE FLEX VIDEO SCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE DEVICE HAD ADHESIVE AROUND LG LENS HAS A CHIP, ADHESIVE AROUND OBJECTIVE LENS HAS A CHIP, AND K-WIRE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473346 ↗
• MalfunctionJun 9, 2026Degraded

  THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE EVALUATION, THE TECHNICIAN OBSERVED ADHESIVE CHIPPING AROUND THE LENSES AND ADHESIVE WEAR DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447203 ↗
• MalfunctionJun 5, 2026Residue After Decontamination

  THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT DIRT ON THE OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25413653 ↗
• MalfunctionJun 3, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE KNOB-WIRE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375890 ↗
• MalfunctionMay 29, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT FOREIGN MATERIAL WAS FOUND ON THE FORCEPS ELEVATOR WIRE, LIKELY DUE TO INCORRECT REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338698 ↗
• MalfunctionMay 6, 2026Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DISTAL COVER ON THE DUODENOVIDEOSCOPE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095189 ↗
• MalfunctionMay 1, 2026Residue After Decontamination

  DURING THE DEVICE EVALUATION OF THE DUODENOVIDEOSCOPE, THERE WAS FOREIGN MATERIAL OBSERVED ON THE FORCEPS ELEVATOR WIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056021 ↗
• MalfunctionFeb 20, 2026Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED CHIPPED ADHESIVE SURROUNDING LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401664 ↗
• MalfunctionJan 14, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE PRESENTED CORROSION ON DISTAL END AND STICKY SWITCH 4. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068696 ↗
• MalfunctionDec 30, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS DISCOVERED DURING THE DEVICE EVALUATION, THE OLYMPUS DUODENOVIDEOSCOPE'S TIP WAS FOUND DIRTY. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926581 ↗
• MalfunctionDec 26, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE DUODENOVIDEOSCOPE UNIVERSAL CORD PROTECTOR ON THE SCOPE CONNECTOR SIDE WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897041 ↗
• MalfunctionDec 9, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATTER ON THE FORCEPS ELEVATOR WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764854 ↗
• MalfunctionDec 8, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED THE FORCEPS ELEVATOR WIRE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743298 ↗
• MalfunctionNov 14, 2025Crack; Material Discolored; Failure to Clean Adequately; Crack; Material Discolored; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOSCOPE EXHIBITED DISCOLORATION INSIDE LIGHT GUIDE LENS, ADHESIVE AROUND THE LIGHT GUIDE LENS HAD CHIPPED AND FORCEPS ELEVATOR WIRE HAD CONTAINED FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560168 ↗
• MalfunctionAug 27, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED THE FORCEPS ELEVATOR WIRE PIPE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902908 ↗
• MalfunctionJul 7, 2025Residue After Decontamination; No Apparent Adverse Event; Residue After Decontamination; No Apparent Adverse Event

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON/IN THE K-WIRE (KNOB WIRE/FORCEPS ELEVATOR WIRE) . THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413294 ↗
• MalfunctionJun 3, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS WITHIN THE FORCEPS ELEVATOR WIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135779 ↗
• MalfunctionApr 28, 2025Corroded; Material Separation; Material Split, Cut or Torn; Corroded; Material Separation; Material Split, Cut or Torn

  DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED THE DISTAL COVER HAD A SLIGHT CUT, THE DISTAL ADHESIVES SEPARATED AND SCRATCHED, AND CORROSION PRESENT ON THE BODY AT THE EXTREMITY OF THE ANGULATION SYSTEM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920094 ↗
• MalfunctionDec 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED THE KNOB WIRE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857209 ↗
• MalfunctionNov 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED KNOB WIRE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757714 ↗
• MalfunctionNov 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED FORCEPS ELEVATOR AND KNOB WIRE HAVE FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757169 ↗