EVIS EXERA DUODENOVIDEOSCOPERecalls & reported problems across all models

We found 2 models of EVIS EXERA DUODENOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2019 and Mar 5, 2026 — classified as 7 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (27 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EVIS EXERA DUODENOVIDEOSCOPE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 25, 2023Open, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0346-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported EVIS EXERA DUODENOVIDEOSCOPE problems

EVIS EXERA DUODENOVIDEOSCOPE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVIS EXERA DUODENOVIDEOSCOPE OLYMPUS TJF TYPE 145

  Endoscopic video imaging system/component, gastroenterology-urology
  1 recall52 reports
• EVIS EXERA DUODENOVIDEOSCOPE OLYMPUS PJF TYPE 160

  Endoscopic video imaging system/component, gastroenterology-urology
  8 reports

Recent EVIS EXERA DUODENOVIDEOSCOPE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Crack

  IT WAS REPORTED THAT THE DUODENOVIDEOSCOPE HAD LIGHT GUIDE AND CHARGED COUPLED DEVICE (CCD) CHIP GLUE IS CRACKED. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515262 ↗
• MalfunctionFeb 5, 2026Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE DUODENOVIDEOSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF ENTEROCCUS HIRA. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274163 ↗
• MalfunctionDec 3, 2025Corroded; Corroded

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE DISTAL END OF THE DUODENOVIDEOSCOPE WAS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704396 ↗
• MalfunctionJul 11, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE DISTAL END WAS PRESENT WITH FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484583 ↗
• MalfunctionJun 25, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329273 ↗
• MalfunctionMar 19, 2025Crack; Crack

  IT WAS REPORTED THAT THERE IS DAMAGE TO THE DISTAL PART OF THE DUODENOVIDEOSCOPE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE ARE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646060 ↗
• MalfunctionMar 18, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE DISTAL END HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635595 ↗
• MalfunctionOct 24, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE DISTAL END OF THE DUODENOVIDEOSCOPE HAD FOREIGN MATERIAL AND RESIDUAL LIQUID. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523214 ↗
• MalfunctionOct 23, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, THE DUODENOVIDEOSCOPE¿S FORCEPS ELEVATOR DOES NOT MOVE DOWN AT ALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514144 ↗
• MalfunctionOct 9, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408012 ↗
• MalfunctionSep 16, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE DUODENOVIDEOSCOPE HAD A GAP ON DISTAL END ADHESION AREA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223224 ↗
• MalfunctionSep 5, 2024Material Separation; Failure to Clean Adequately; Material Separation; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED DISTAL END HAD FOREIGN MATERIAL AND A GAP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147955 ↗
• MalfunctionAug 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL UNDER THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084984 ↗
• MalfunctionAug 5, 2024Device Reprocessing Problem; Device Reprocessing Problem

  DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL AT THE DISTAL END ADHESIVE BETWEEN THE SERVER PLUG-IN AND THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913434 ↗
• MalfunctionAug 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL FOUND INSIDE THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913420 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports