EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190I (REF N3802440)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA lll COLONOVIDEOSCOPE (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names 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 endoscope for examining the colon. Many reports describe contamination found on scopes and cleaning that was not adequate. The records include 1,944 reports, 12 injuries and no deaths. There is 1 recall, open since September 2023, because some repaired scopes had water left in the channel, a possible source of contamination. Reports rose from 252 in the year before to 472 in the most recent year.
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
- 1,967
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,967 adverse event reports that list this exact device (DI 04953170305177), received between May 11, 2018 and Sep 30, 2026 — classified as 12 injuries, 1,955 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (782 reports).
1 FDA recall record name this device's identifier, 1 still open.
8 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.
Reports received per month
Recalls naming this device
- 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-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Microbial Contamination of Device782
- Failure to Clean Adequately709
- Device Reprocessing Problem177
- Communication or Transmission Problem98
- No Display/Image74
- Contamination62
- Poor Quality Image35
- Contamination /Decontamination Problem32
Patient problems
- No Clinical Signs, Symptoms or Conditions1,764
- No Known Impact Or Consequence To Patient134
- No Consequences Or Impact To Patient49
- Insufficient Information14
- Perforation5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Caustic/Chemical Burns1
Recent adverse event reports
The 25 most recent of 1,967 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
The customer reported that no image was displayed 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 50949574 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, foreign material was observed in the Air Water channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948661 ↗MalfunctionSep 30, 2026Microbial Contamination of Device
It was reported that the Colonovideoscope tested positive for an unspecified amount of Pseudomonas. The issue was found during a routine culture of the scope. The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944710 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that the scope cover unit had foreign objects. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941996 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display
The customer reported image flickering during inspection for use involving an Olympus colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941963 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
The customer reported scope communication error B30 during inspection for use involving an Olympus colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941852 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Poor Quality Image
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, video flickering, vertical lines, and a pixelated image were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936528 ↗MalfunctionSep 28, 2026Microbial Contamination of Device
It was reported that, during reprocessing, the COLONOVIDEOSCOPE tested positive for 4Colony Forming Units (CFUs) of pseudomonas aeruginosa. The device was retested on July 27, 2026, and it tested positive for 7 CFUs of unspecified bacteria. The device was tested again on August 04, 2026, and tested positive for more than >66 CFUs of unspecified bacteria. All channels were sampled. The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918426 ↗MalfunctionSep 28, 2026Communication or Transmission Problem; Output Problem
The customer reported not read by the light source during an inspection for use involving an Olympus Colonovideoscope. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916649 ↗MalfunctionSep 25, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896697 ↗MalfunctionSep 24, 2026Gas/Air Leak
The customer reported dirty instrument during the leak test during reprocessing involving a colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888666 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that connecting tube, bending section cover, adhesives around light guide lens, objective lens, c-cover, jet tube and scope connector case unit and protector of universal cord on scope connector side had foreign object. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886477 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer reported the colonovideoscope head had a separate issue. During the initial evaluation of the device it was observed, Air/Water Channel has foreign material. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885984 ↗MalfunctionSep 24, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876586 ↗MalfunctionSep 23, 2026Microbial Contamination of Device
It was reported that, during reprocessing, the Colonovideoscope tested positive for >100 Colony Forming Units (CFUs) of Klebsiella pneumoniae. All channels were sampled. The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872360 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857955 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for a separate issue. During the device analysis, the technical assistance indicates that a foreign objects auxiliary jet channel was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850383 ↗MalfunctionSep 21, 2026Corroded
During onsite inspection of colonovideoscope, it was found . There was no patient involvement.The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device it was observed that Connector Equalization valve cover was corroded. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835273 ↗MalfunctionSep 19, 2026Erratic or Intermittent Display; Poor Quality Image
It was reported that the customer allegation was involving an Olympus colonovideoscope.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832748 ↗MalfunctionSep 18, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that white foreign material was present within the jet channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813483 ↗MalfunctionSep 15, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781621 ↗MalfunctionSep 14, 2026Failure to Clean Adequately
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device repair technician found white foreign material jet tube, there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50750596 ↗MalfunctionSep 14, 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. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50750473 ↗MalfunctionSep 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740359 ↗MalfunctionSep 11, 2026Microbial Contamination of Device
Patient problems: Insufficient Information
MAUDE report 50738683 ↗
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, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0341-2024 · Sep 25, 2023 · Open, ClassifiedColonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
- Z-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS 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
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 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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