EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III COLONOVIDEOSCOPE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III colonoscope is a flexible scope used for colon exams. Its 2,683 reports mostly describe scopes not cleaning adequately after reprocessing, residue left after cleaning, no display, and poor image quality. The reports include no deaths and 22 injuries, and most list no clinical signs for the patient. Reports in the last 12 months (2,091) are far above the previous 12 months (206). There are 2 open recalls, covering scopes repaired without adhesive and scopes returned with wet channels.
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
- 2,828
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,828 adverse event reports that list this exact device (DI 04953170416118), received between Aug 12, 2021 and Sep 30, 2026 — classified as 24 injuries, 2,804 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1,257 reports).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K192793); 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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
Device problems
- Failure to Clean Adequately1,257
- Communication or Transmission Problem474
- Residue After Decontamination311
- No Display/Image278
- Poor Quality Image245
- Device Reprocessing Problem130
- Microbial Contamination of Device114
- Erratic or Intermittent Display74
Patient problems
- No Clinical Signs, Symptoms or Conditions2,800
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Insufficient Information9
- Hemorrhage/Blood Loss/Bleeding4
- Hepatitis3
- Bowel Perforation2
- Foreign Body In Patient2
- Abdominal Pain1
Recent adverse event reports
The 25 most recent of 2,828 reports, 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, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954708 ↗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, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945015 ↗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, 2026Erratic or Intermittent Display; No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937737 ↗MalfunctionSep 29, 2026Residue After Decontamination
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the white residue in air water channel on the light guide channel side was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935932 ↗MalfunctionSep 29, 2026Contamination; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934409 ↗MalfunctionSep 29, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932745 ↗MalfunctionSep 29, 2026No Display/Image; Communication or Transmission Problem
The customer returned the Colonovideoscope to the service center for a separate issue. During the device analysis, the Investigator indicated that no image and error B30 was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928234 ↗MalfunctionSep 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925262 ↗MalfunctionSep 28, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924601 ↗MalfunctionSep 28, 2026Residue After Decontamination
The customer returned the Colonovideoscope to the service center for a separate issue. During the initial evaluation of the device, the inside of the auxiliary water flow had white residue. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917964 ↗MalfunctionSep 28, 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 in the air/water cylinder and channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917828 ↗MalfunctionSep 28, 2026Residue After Decontamination
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the white residue in air water channel and cylinder was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916832 ↗MalfunctionSep 28, 2026Residue After Decontamination
The customer reported the Olympus colonovideoscope had a separate issue. During the initial evaluation of the device it was observed, White residue on air water channel and cylinder and auxiliary channel were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915990 ↗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 on both sides of the channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915043 ↗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 supply channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914970 ↗MalfunctionSep 28, 2026Overheating of Device
The customer reported the Colonovideoscope had a separate issue. During the initial evaluation of the device it was observed that, the C-cover and C-cover insulation had a burn. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914799 ↗MalfunctionSep 28, 2026No Display/Image
The customer reported that the image was blanking out during inspection for use involving an Olympus Colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914764 ↗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 and the air/water cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914709 ↗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 in the channel and cylinder side. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912529 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192793. One submission often covers many models, so check the product and lot details in each record.
- Z-1212-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190TL.
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall520 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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