EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (REF N5992940)Recalls & reported problems
Olympus Medical Systems Corp. · EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V · Class 2
All models of EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus duodenoscope is a flexible scope used to examine the duodenum. Reports most often describe cleaning failures, cracks and peeling, and some mention microbial contamination. The device appears in 4,675 reports, including 10 deaths and 499 injuries. It has 4 open recalls about cleaning and reprocessing, including water left in the channel after repair. Reports rose to 2,291 in the last 12 months from 321 before.
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
- 4,900
- Deaths reported
- 10
- Injuries reported
- 498
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 4,900 adverse event reports that list this exact device (DI 04953170405563), received between Jan 6, 2021 and Sep 30, 2026 — classified as 10 deaths, 498 injuries, 4,392 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (955 reports).
4 FDA recall records name this device's identifier, 4 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 ↗
- May 5, 2025Class IIOpen, Classified
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Z-1911-2025 · Root cause: Labeling design · Recall details · FDA record ↗
- 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 ↗
- Jul 27, 2023Class IIOpen, Classified
Recent reports of patient infection.
Z-2467-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately955
- Crack838
- Peeled/Delaminated749
- Detachment of Device or Device Component715
- Microbial Contamination of Device337
- Material Fragmentation288
- Degraded251
- Device Reprocessing Problem196
Patient problems
- No Clinical Signs, Symptoms or Conditions4,617
- Unspecified Tissue Injury88
- Foreign Body In Patient84
- Hemorrhage/Blood Loss/Bleeding27
- Laceration(s)23
- Unspecified Infection13
- Bacterial Infection12
- Laceration(s) of Esophagus11
Recent adverse event reports
The 25 most recent of 4,900 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported the duodenovideoscope had a separate issue. During the initial evaluation of the device, it was observed that objective and light guide lens had chipped glue. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950101 ↗MalfunctionSep 30, 2026Degraded
The customer returned the Duodenovideoscope to the service center for a annual maintenance. During the initial evaluation of the device, lifting of the lens adhesive was observed. No patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949265 ↗MalfunctionSep 30, 2026Material Fragmentation
The customer returned the duodenovideoscope to the service center for a separate issue. During the initial evaluation of the returned device chipped adhesive was found at the objective and light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949249 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported the duodenovideoscope, which is an Olympus asset, with no reported complaint. During the initial evaluation of the device, it was observed that there was peeling on the cement on the objective and light guide lens. There was no patient involvement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948951 ↗MalfunctionSep 30, 2026Material Fragmentation
The customer returned the duodenovideoscope to the service center for annual inspection. During the device analysis, chipped adhesive was found around the objective and light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948880 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Integrity Problem
During the onsite inspection of the duodenovideoscope, areas of missing or damaged sealing agent were observed around the objective lens and the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947942 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis a foreign material was found inside the forceps passage. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947916 ↗MalfunctionSep 30, 2026Break; Failure to Clean Adequately
The customer returned the duodenovideoscope for a separate issue. During the device evaluation, the air/water channel was found to have white residue. A cracked c-cover was also found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945608 ↗MalfunctionSep 30, 2026Material Fragmentation
During inspection of the Duodenovideoscope, chipped adhesive around the objective lens and light guide lens was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945533 ↗MalfunctionSep 30, 2026Crack
The customer reported the Duodenovideoscope for a separate issue. During the initial evaluation of the returned device, chipped glue was observed on the objective (OB) lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945503 ↗MalfunctionSep 30, 2026Crack
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis chipped glue was found at the objective lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945256 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the Duodenovideoscope for a separate issue. During the initial evaluation of the device, the objective lens and the light guide lens had chipped adhesive. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944920 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940744 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Crack
The customer returned the Duodenovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates light guide lens and objective lens had chip, deep scratches, and the adhesive around the lens had a gap and the adhesive around the objective and light guide lens had lifted off and chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936159 ↗MalfunctionSep 29, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935708 ↗MalfunctionSep 29, 2026Crack; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935475 ↗MalfunctionSep 29, 2026Crack; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935318 ↗MalfunctionSep 29, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934998 ↗MalfunctionSep 29, 2026Crack; Material Fragmentation
The customer returned the duodenovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, the light guide lens and objective lens had chipped glue, and a chipped lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933179 ↗MalfunctionSep 29, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932156 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931987 ↗MalfunctionSep 29, 2026Crack; Material Fragmentation
The customer returned the Duodenovideoscope to the service center for a separate issue. During initial evaluation of the device, the objective lens and the light guide lens had chipped glue and chipped lenses. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927600 ↗MalfunctionSep 29, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926948 ↗MalfunctionSep 29, 2026Material Fragmentation; Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926864 ↗MalfunctionSep 28, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926708 ↗
Other Duodenoscope and accessories, flexible/rigid devices
- 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
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Medical Systems Corp. · Duodenoscope And Accessories, Flexible/Rigid1 recall381 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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