EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190L (REF N3802540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,513 adverse event reports that list this exact device (DI 04953170305191), received between Nov 15, 2018 and Sep 30, 2026 — classified as 2 deaths, 29 injuries, 2,482 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (1,033 reports).

3 FDA recall records name this device's identifier, 3 still open.

6 other recalls cover devices cleared under the same FDA submission (K131780); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1211-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Oct 16, 2023Class IIOpen, Classified

   Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

   Z-0419-2024 · Root cause: Process control · 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,513 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954447 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952653 ↗
• MalfunctionSep 30, 2026Residue After Decontamination

  The customer reported the colonovideoscope had a black piece that had removed from inside the tube. During the initial evaluation of the device, foreign material in the biopsy channel was observed. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950806 ↗
• MalfunctionSep 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950006 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign material was observed inside the nozzle, and white residue was observed within the air/water supply channel. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945620 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, Air water supply, channel and cylinder had white residue. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945504 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  The customer reported that the colonovideoscope had a separate issue. During the initial evaluation of the returned device, a dirty angle wire was observed. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941790 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  It was reported that the error message Scope Communication Error occurred during a diagnostic colonoscopy while using the colonovideoscope. The procedure was completed with a similar device. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941772 ↗
• MalfunctionSep 29, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938889 ↗
• MalfunctionSep 29, 2026No Display/Image; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938711 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed in the auxiliary water flow, and the nozzle was clogged with white residue. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937208 ↗
• MalfunctionSep 29, 2026No Display/Image

  The customer reported no image during inspection for use involving an Olympus colonovideoscope. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935818 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  The customer reported that the colonovideoscope instrument was dirty during reprocessing. During the initial evaluation of the device, the connecting tube was observed to be sticky. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935736 ↗
• MalfunctionSep 29, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935701 ↗
• MalfunctionSep 29, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934362 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931799 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed in the air/water channel and cylinder and in the auxiliary water channel. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931770 ↗
• MalfunctionSep 29, 2026Residue After Decontamination; Communication or Transmission Problem

  The customer reported the Colonovideoscope displayed an E216 scope communication error. During the initial evaluation of the device, that white residue in the air/water channel and cylinder was observed. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927292 ↗
• MalfunctionSep 29, 2026Device Reprocessing Problem

  The customer reported that the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the light guide lens had foreign objects. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927120 ↗
• MalfunctionSep 28, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926190 ↗
• MalfunctionSep 28, 2026No Display/Image

  The customer reported static screen without image during inspection for use involving an Olympus colonovideoscope. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923241 ↗
• MalfunctionSep 28, 2026Erratic or Intermittent Display

  The customer reported an image that was all staticky, like snow during inspection for use involving an Olympus Colonovideoscope. There was no patient involvement reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917260 ↗
• MalfunctionSep 28, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916018 ↗
• MalfunctionSep 28, 2026Failure to Clean Adequately

  The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that foreign objects were in the air water tube and cylinder and jet tube. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915287 ↗
• MalfunctionSep 28, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed within the air/water channel, air/water cylinder, and auxiliary water tube. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.

• Z-1210-2024 · Jan 11, 2024 · Open, Classified
  Colonoscope, Model Number PCF-H190DL.
• Z-0416-2024 · Oct 16, 2023 · Open, Classified
  GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0418-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0417-2024 · Oct 16, 2023 · Open, Classified
  GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0415-2024 · Oct 16, 2023 · Open, Classified
  CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
• Z-0056-2025 · Sep 14, 2023 · Open, Classified
  EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil