EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VRecalls & reported problems across all models

We found 2 models of EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 5,281 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2021 and Sep 30, 2026 — classified as 10 deaths, 550 injuries, 4,721 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (1,055 reports).

4 FDA recall records name at least one of these models by its device 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. 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

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V 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.

1. 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 · names 2 of these models · Recall details · FDA record ↗

2. 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 ↗

3. 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 ↗

4. 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 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V problems

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

  Duodenoscope and accessories, flexible/rigid
  4 recalls10 deaths4,900 reports
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

  Duodenoscope And Accessories, Flexible/Rigid
  1 recall381 reports

Recent EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V adverse event reports

The 15 most recent reports across all models, 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 ↗

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
• HD CAMERA HEAD2 models · 5,217 reports
• 4K CAMERA HEAD3 models · 4,926 reports