DUODENOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DUODENOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 602
- Deaths reported
- 4
- Injuries reported
- 7
- Recalls
- 1
We found 2 models of DUODENOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 602 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2019 and Sep 17, 2026 — classified as 4 deaths, 7 injuries, 591 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (258 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
Reports received per month, all models
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.
- 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 DUODENOVIDEOSCOPE problems
Device problems
- Failure to Clean Adequately258
- Contamination108
- Device Contamination with Chemical or Other Material59
- Device Reprocessing Problem57
- Contamination /Decontamination Problem56
- Residue After Decontamination56
- Break26
- Crack25
Patient problems
- No Clinical Signs, Symptoms or Conditions573
- No Consequences Or Impact To Patient17
- Hemorrhage/Blood Loss/Bleeding3
- Insufficient Information3
- Pancreatitis3
- Pneumonia3
- Cholangitis2
- Perforation2
DUODENOVIDEOSCOPE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DUODENOVIDEOSCOPE TJF-150Endoscopic video imaging system/component, gastroenterology-urology4 deaths413 reports
- DUODENOVIDEOSCOPE TJF-150Endoscopic video imaging system/component, gastroenterology-urology1 recall189 reports
Recent DUODENOVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 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 ↗MalfunctionJul 21, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25894518 ↗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 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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