EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (REF N5992941)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (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 EVIS EXERA III duodenoscope is a flexible endoscope. Its 366 reports include 314 malfunctions and 52 injuries, with no deaths. Many describe cleaning that fails, parts that detach, microbial contamination and cracks, and 13 mention a foreign body in the patient. Reports rose from 28 in the 12 months before to 102 in the latest 12 months. One recall is open, begun in October 2025, over updated reprocessing materials after continued reports of positive cultures and infections.
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
- 381
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 04953170452024), received between Nov 10, 2021 and Sep 29, 2026 — classified as 52 injuries, 329 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (100 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
Recalls naming this device
- Oct 14, 2025Class IIOpen, Classified
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Z-0579-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately100
- Detachment of Device or Device Component68
- Microbial Contamination of Device60
- Crack33
- Material Fragmentation21
- Device Reprocessing Problem17
- Contamination16
- Peeled/Delaminated15
Patient problems
- No Clinical Signs, Symptoms or Conditions348
- Foreign Body In Patient13
- Airway Obstruction5
- Unspecified Infection5
- Bacterial Infection3
- Insufficient Information3
- Device Embedded In Tissue or Plaque2
- Fungal Infection2
Recent adverse event reports
The 25 most recent of 381 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Crack; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935674 ↗MalfunctionSep 22, 2026Crack
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device, Objective and light guide lens had crack glue was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852613 ↗MalfunctionSep 22, 2026Material Fragmentation
During inspection of the Duodenovideoscope, chipping of the adhesive around the objective lens and the light guide lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851955 ↗MalfunctionSep 21, 2026Crack; Peeled/Delaminated; Material Puncture/Hole
The customer returned the Duodenovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates the objective and light guide lens had pinholes on the glue and peeling on the cement and the glue was missing from the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843847 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
The customer returned the duodenovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, Objective lens and light guide lens had chipped adhesive was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820394 ↗MalfunctionSep 18, 2026Material Fragmentation
The customer reported that the Duodenovideoscope had a separate issue. During the initial evaluation of the device, chipped adhesive around the objective lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820327 ↗MalfunctionSep 18, 2026Degraded
During the initial evaluation of the Duodenovideoscope device, it was observed that the Distal tip rubber adhesive was irregular. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817886 ↗MalfunctionSep 17, 2026Material Fragmentation
The customer reported the Duodenovideoscope had an irregular adhesive on the distal tip rubber. The event occurred during maintenance. During the evaluation of the returned device, adhesive on the rubber (tip rubber) has a chip was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808839 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
During onsite inspection of duodenovideoscope, it was found missing adhesive at objective lens and light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808706 ↗MalfunctionSep 16, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796522 ↗MalfunctionSep 10, 2026Corroded; Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721151 ↗MalfunctionSep 10, 2026Flaked
The customer returned the duodenovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the device, there was missing glue around the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714056 ↗MalfunctionSep 9, 2026Residue After Decontamination; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696337 ↗MalfunctionSep 9, 2026Corroded; Degraded
The customer reported the duodenovideoscope had uneven adhesive on distal tip during maintenance. During the initial evaluation of the device, it was observed there was corrosion in the suction chamber. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694999 ↗MalfunctionSep 8, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674942 ↗MalfunctionSep 1, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554082 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554064 ↗MalfunctionSep 1, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553795 ↗MalfunctionAug 31, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532153 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532053 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459549 ↗MalfunctionAug 26, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454455 ↗MalfunctionAug 21, 2026Crack; Peeled/Delaminated
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379365 ↗MalfunctionAug 18, 2026Crack
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis, there was chipped glue on the objective lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299240 ↗MalfunctionAug 18, 2026Degraded; Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299146 ↗
Other Duodenoscope And Accessories, Flexible/Rigid devices
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Medical Systems Corp. · Duodenoscope and accessories, flexible/rigid4 recalls10 deaths4,900 reports
- PENTAX Medical ED34-i10T2Hoya Corporation · duodenoscope and accessories, flexible/rigid826 reports
- EXALT™ Model D M00542420Boston Scientific Corporation · Duodenoscope and accessories, flexible/rigid4 recalls1 death252 reports
- EXALT™ Model D M0054242CE0Boston Scientific Corporation · Duodenoscope and accessories, flexible/rigid4 recalls1 death38 reports
- CRE Wireguided M00558470Boston Scientific Corporation · duodenoscope and accessories, flexible/rigid1 recall17 reports
- CRE Wireguided M00558460Boston Scientific Corporation · duodenoscope and accessories, flexible/rigid1 recall11 reports
- FUJIFILM ED-580XTFujifilm Corporation · Duodenoscope And Accessories, Flexible/Rigid60 reports
- PENTAX ED-3490TKHoya Corporation · duodenoscope and accessories, flexible/rigid43 reports
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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