EVIS EXERA III COLONOVIDEOSCOPERecalls & reported problems across all models

We found 6 models of EVIS EXERA III COLONOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 6,117 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2018 and Sep 30, 2026 — classified as 62 injuries, 6,055 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (2,565 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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 COLONOVIDEOSCOPE 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. 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-1213-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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-1212-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. 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-1210-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. 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-0418-2024 · Root cause: Process control · Recall details · FDA record ↗

5. 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 · names 6 of these models · Recall details · FDA record ↗

Most reported EVIS EXERA III COLONOVIDEOSCOPE problems

EVIS EXERA III COLONOVIDEOSCOPE models

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

• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DL

  Colonoscope and accessories, flexible/rigid
  3 recalls2,830 reports
• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L

  Endoscope, accessories, narrow band spectrum
  2 recalls2,828 reports
• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL

  Colonoscope and accessories, flexible/rigid
  2 recalls184 reports
• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DI

  Colonoscope and accessories, flexible/rigid
  1 recall164 reports
• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TI

  Endoscope, accessories, narrow band spectrum
  1 recall77 reports
• EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190I

  Colonoscope and accessories, flexible/rigid
  1 recall34 reports

Recent EVIS EXERA III COLONOVIDEOSCOPE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954958 ↗
• MalfunctionSep 30, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954920 ↗
• MalfunctionSep 30, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image; Communication or Transmission Problem; Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954835 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954708 ↗
• MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949736 ↗
• MalfunctionSep 30, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949295 ↗
• MalfunctionSep 30, 2026Erratic or Intermittent Display

  The customer reported that the camera image was intermittently cutting in and out during a diagnostic procedure involving an Olympus Colonovideoscope. The procedure was completed using the same device. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946817 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue on the channel and cylinder was observed. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946810 ↗
• MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem

  The customer reported that the colonovideoscope displayed a connection error during inspection for use. During the initial evaluation of the device, no image was observed. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946029 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945015 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  During the initial evaluation of the colonovideoscope, it was found that white foreign material was present within the air/water tube and air/water cylinder. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943255 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941468 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940880 ↗
• MalfunctionSep 29, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939151 ↗
• MalfunctionSep 29, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938094 ↗

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 DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports
• 4K CAMERA HEAD3 models · 4,926 reports