EVIS EXERA DUODENOVIDEOSCOPE OLYMPUS TJF TYPE 145Recalls & reported problems

All models of EVIS EXERA DUODENOVIDEOSCOPE (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Olympus TJF-145 duodenovideoscope is a thin flexible scope used to look at the duodenum and bile ducts. The 53 reports mostly describe cleaning and reprocessing problems — scopes not cleaned adequately, microbial contamination, and moisture left in the channel — along with cracks, corrosion, and peeling surfaces at the scope's tip. Four reports mention injuries; no deaths were reported. One open recall, started in September 2023, involves scopes returned after repair having a wet channel because the air drying process was not validated.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 52
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04953170339950), received between Oct 3, 2019 and Mar 5, 2026 — classified as 4 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (26 reports).

1 FDA recall record name this device's 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, 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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Sep 25, 2023Class IIOpen, 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 problems

Device problems

Failure to Clean Adequately26
Microbial Contamination of Device10
Device Reprocessing Problem6
Contamination4
Crack4
Break3
Corroded3
Peeled/Delaminated3

Patient problems

No Clinical Signs, Symptoms or Conditions44
No Consequences Or Impact To Patient4
Injury2
Cholangitis1
Fever1
Perforation1
Unspecified Infection1

Recent adverse event reports

The 25 most recent of 52 reports, 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 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 ↗
MalfunctionAug 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED WHITISH FOREIGN MATERIAL INSIDE THE AIR/WATER TUBE, AIR/WATER CYLINDER AND THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19906098 ↗
MalfunctionJul 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE GROOVES OF THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19684200 ↗
MalfunctionJun 18, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED FORCEPS ELEVATOR HAD FOREIGN MATERIAL OR STAIN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19555581 ↗
MalfunctionJun 14, 2024Corroded; Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE DUODENOVIDEOSCOPE EXHIBITED CORROSION AT THE DISTAL TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536097 ↗
MalfunctionMay 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER TUBE, CYLINDER, AND ELEVATOR CHANNEL PLUG. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367336 ↗
MalfunctionMar 26, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE DUODENOVIDEOSCOPE LIGHT GUIDE (LG) LENS ADHESIVE APPEARS TO CONTAIN MARKS OF FOREIGN MATERIAL THAT RESEMBLE CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980785 ↗
MalfunctionMar 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE DUODENOVIDEOSCOPE EXHIBITED LIGHT GUIDE LENS ADHESIVE WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18968802 ↗
MalfunctionMar 19, 2024Crack; Failure to Clean Adequately; Crack; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE AW-CYLINDER (AIR, WATER) HAD FOREIGN OBJECTS. THE AW-TUBE (AIR, WATER) HAD FOREIGN OBJECTS. THE DISTAL END HAD FOREIGN OBJECTS AND WAS CRACKED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18938226 ↗
MalfunctionMar 14, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED THE DISTAL END, THE ADHESIVE AROUND THE OBJECTIVE LENS AND LIGHT GUIDE LENS HAD CORROSION AND FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18907281 ↗
MalfunctionFeb 27, 2024Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED A GAP IN ADHESIVE AREA BETWEEN PLASTIC COVER AND DISTAL END AND A STAIN INSIDE OF THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792784 ↗
MalfunctionFeb 1, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE DUODENOVIDEOSCOPE TESTED POSITIVE FOR 100 (CFU) COLONY FORMING UNITS OF ESCHERICHIA COLI. 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 18623574 ↗

Device details

UDI-DI	`04953170339950`
Brand	EVIS EXERA DUODENOVIDEOSCOPE
Model	OLYMPUS TJF TYPE 145
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 16, 2023

Device type (GMDN): Flexible video duodenoscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device.

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 · each recall links to the FDA recall notice
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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