DUODENOVIDEOSCOPE TJF-150 (UDI 04953170307553)Recalls & reported problems

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 duodenovideoscope is an endoscope used to view the bile and pancreatic ducts. Many of its 187 reports describe poor cleaning, residue after reprocessing, and cracks or breaks. There are 2 injury reports and no deaths. There is 1 open recall, from September 2023, over channels that may stay wet after repair. Reports rose from 42 in the year before to 84 in the latest year.

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: 189
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 04953170307553), received between Apr 18, 2019 and Sep 17, 2026 — classified as 2 injuries, 187 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (64 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 Adequately64
Residue After Decontamination48
Crack17
Break14
Device Reprocessing Problem14
Device Contamination with Chemical or Other Material11
Contamination /Decontamination Problem7
Material Discolored7

Patient problems

No Clinical Signs, Symptoms or Conditions170
No Consequences Or Impact To Patient15
Insufficient Information2
Pneumonia2
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 17, 2026Failure to Clean Adequately
The customer reported that the Duodenovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the universal cord was sticky. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804318 ↗
MalfunctionSep 15, 2026Residue After Decontamination
The customer returned the Duodenovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that the forceps elevator wire had foreign objects. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775184 ↗
MalfunctionAug 28, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500418 ↗
MalfunctionJul 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087779 ↗
MalfunctionJul 29, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067422 ↗
MalfunctionJul 27, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046010 ↗
MalfunctionJun 24, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT FOREIGN MATERIAL IN THE FORCEPS ELEVATOR WIRE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606837 ↗
MalfunctionJun 24, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT FOREIGN MATERIAL IN FORCEPS ELEVATOR WIRE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606784 ↗
MalfunctionJun 24, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT FOREIGN MATERIAL IN THE FORCEPS ELEVATOR WIRE AND A STAIN ON THE LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606742 ↗
MalfunctionJun 23, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE K-WIRE HAS FOREIGN OBJECTS. THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED, AND CAUSE COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600892 ↗
MalfunctionJun 17, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD FOREIGN OBJECT ON FORCEPS ELEVATOR WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540602 ↗
MalfunctionJun 10, 2026Material Fragmentation
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIP IN THE ADHESIVE AROUND THE LG LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25466087 ↗
MalfunctionJun 10, 2026Pitted
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THAT A CHIPPED ADHESIVE AROUND THE LIGHT GUIDE AND OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459369 ↗
MalfunctionJun 10, 2026Crack
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THE ADHESIVE OF THE LIGHT GUIDE AND OBJECTIVE LENSES WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25458656 ↗
MalfunctionJun 4, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TECHNICIAN INDICATED THAT THERE WERE FOREIGN OBJECTS ON THE KNOB WIRE DUE TO IMPROPER REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25397730 ↗
MalfunctionJun 3, 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, THE CAUSE OF WHICH COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383786 ↗
MalfunctionJun 1, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR AN UNRELATED ISSUE. DURING THE DEVICE EVALUATION, TECHNICIANS IDENTIFIED THAT THE KNOB WIRE CONTAINED FOREIGN OBJECTS. THE IDENTITY OF THE FOREIGN MATERIAL AND THE ROOT CAUSE OF WHY IT REMAINED IN THE DEVICE COULD NOT BE DEFINITIVELY DETERMINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355297 ↗
MalfunctionJun 1, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR AN UNRELATED ISSUE. DURING THE DEVICE EVALUATION, TECHNICIANS IDENTIFIED THAT THE UNIVERSAL CORD WAS STICKY AND THE KNOB WIRE CONTAINED FOREIGN OBJECTS. BASED ON THE COMPLETED INVESTIGATION, THE IDENTITY OF THE FOREIGN OBJECT AND THE ROOT CAUSE OF WHY IT REMAINED IN THE DEVICE COULD NOT BE DEFINITIVELY DETERMINED. IT IS LIKELY THAT THE REPROCESSING DEVIATED FROM THE INSTRUCTION FOR USE. ADDITIONALLY, THE CAUSE OF THE STICKINESS ON THE UNIVERSAL CORD WAS NOT ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354956 ↗
MalfunctionJun 1, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING TESTING, FOREIGN OBJECTS WERE IDENTIFIED ON THE FORCEPS ELEVATOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350826 ↗
MalfunctionMay 29, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT THE ADHESIVE AROUND THE LIGHT GUIDE LENS AND OBJECTIVE LENS HAD CHIPPED, THE CAUSE OF WHICH COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338251 ↗
MalfunctionMay 27, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT FOREIGN OBJECTS IN FORCEPS ELEVATOR WIRE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25297653 ↗
MalfunctionMay 22, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL ON THE FORCEPS ELEVATOR WIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257950 ↗
MalfunctionMay 6, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE HAD FOREIGN MATERIAL IN THE FORCEPS ELEVATOR WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25101618 ↗
MalfunctionMay 6, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN K-WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25100361 ↗
MalfunctionMay 5, 2026Residue After Decontamination
DURING THE DEVICE EVALUATION, FOREIGN OBJECTS WERE OBSERVED ON THE DUODENOVIDEOSCOPE'S KNOB WIRE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080690 ↗

Device details

UDI-DI	`04953170307553`
Brand	DUODENOVIDEOSCOPE
Model	TJF-150
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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