EVIS EXERA II DUODENOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one EVIS EXERA II DUODENOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,346
- Deaths reported
- 15
- Injuries reported
- 183
- Recalls
- 2
We found 3 models of EVIS EXERA II DUODENOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 3,346 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2017 and Sep 30, 2026 — classified as 15 deaths, 183 injuries, 3,148 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1,210 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
EVIS EXERA II 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, 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 ↗
- Nov 2, 2021Class IIOpen, Classified
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
Z-0379-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported EVIS EXERA II DUODENOVIDEOSCOPE problems
Device problems
- Failure to Clean Adequately1,210
- Device Reprocessing Problem440
- Microbial Contamination of Device389
- Crack338
- Contamination236
- Degraded157
- Device Contamination with Chemical or Other Material143
- Break133
Patient problems
- No Clinical Signs, Symptoms or Conditions2,787
- No Known Impact Or Consequence To Patient145
- No Consequences Or Impact To Patient144
- No Patient Involvement80
- Unspecified Infection75
- Bacterial Infection53
- Hemorrhage/Blood Loss/Bleeding26
- Pancreatitis23
EVIS EXERA II DUODENOVIDEOSCOPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VEndoscope, accessories, narrow band spectrum6 deaths2,362 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VEndoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VEndoscope, accessories, narrow band spectrum1 recall6 deaths331 reports
Recent EVIS EXERA II DUODENOVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Reprocessing Problem; Crack
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device it was observed foreign objects inside of light guide lens, chipping of adhesive around objective lens and chipping of adhesive around light guide lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951172 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
No additional information provided by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950773 ↗MalfunctionSep 30, 2026Poor Quality Image
The customer returned the Olympus Duodenovideoscope to the service center for a separate issue. During the initial evaluation of the device, striping and flacking of the image was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949257 ↗MalfunctionSep 30, 2026Material Discolored
The customer returned the Duodenovideoscope for a separate issue. During the initial evaluation of the device, a stain was observed inside the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943405 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935636 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934554 ↗MalfunctionSep 28, 2026Corroded; Residue After Decontamination
The customer returned the Duodenovideoscope to the service center for a separate issue. During the initial evaluation of the returned device a corroded cylinder and Forceps elevator has foreign material was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919665 ↗MalfunctionSep 28, 2026Degraded
The customer reported the Duodenovideoscope for a separate issue. During the initial evaluation of the device, adhesive wear around the lenses was observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918790 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the Duodenovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates forceps elevator had foreign material. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917362 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the Duodenovideoscope for a separate issue. During the evaluation of the device, Forceps elevator foreign material was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895711 ↗MalfunctionSep 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892402 ↗MalfunctionSep 24, 2026Material Discolored; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892002 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889865 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device, the control knob was found to require cleaning, and foreign material was observed on the forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889748 ↗MalfunctionSep 23, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876469 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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