EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190I (REF N3802640)Recalls & reported problems
Olympus Medical Systems Corp. · "PCF-H190I EVIS EXERA III HD SLIM COLONOS" · 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 scope used to examine the colon. Many of its 448 reports describe scopes that were not cleaned adequately or tested positive for contamination. The reports list 1 injury, no deaths and 447 malfunctions, and reports rose to 137 in the most recent year from 84 in the year before. There is 1 recall, open since September 2023, over scopes that may keep water in their channels, which could lead to infection.
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
- 460
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 460 adverse event reports that list this exact device (DI 04953170305214), received between Aug 23, 2018 and Sep 30, 2026 — classified as 1 injury, 459 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (245 reports).
1 FDA recall record name this device's identifier, 1 still open.
7 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately245
- Microbial Contamination of Device94
- Device Reprocessing Problem62
- Communication or Transmission Problem25
- No Display/Image20
- Poor Quality Image15
- Corroded8
- Contamination6
Patient problems
- No Clinical Signs, Symptoms or Conditions435
- No Known Impact Or Consequence To Patient17
- No Consequences Or Impact To Patient5
- Bacterial Infection2
- Injury1
- Perforation1
Recent adverse event reports
The 25 most recent of 460 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
The customer reported that the colonovideoscope displayed no image during inspection for use. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945283 ↗MalfunctionSep 29, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934858 ↗MalfunctionSep 27, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909729 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904057 ↗MalfunctionSep 25, 2026No Display/Image; Communication or Transmission Problem
The customer reported black screen and scope communication errors (E216 and B30) involving an Olympus colonovideoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893090 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects were observed in the air/water cylinder, air/water tube, and C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883944 ↗MalfunctionSep 23, 2026Failure to Clean Adequately
The customer reported disinfection cycle failure at reprocessing involving an Olympus colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863526 ↗MalfunctionSep 22, 2026Corroded; Poor Quality Image; Communication or Transmission Problem; Output Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, a B30 (Scope Communication Error), noisy image, corrosion on the connecting tube, and no illumination were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857259 ↗MalfunctionSep 18, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, foreign object on auxiliary jet tube was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812900 ↗MalfunctionSep 17, 2026Poor Quality Image
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, Black and white lines appear in image observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804870 ↗MalfunctionSep 15, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, sticky connecting tube. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775961 ↗MalfunctionSep 10, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope to the service center for evaluation related to separate issue. During testing, the service technician identified the device had foreign object in the adhesive of bending section cover and white foreign material in the Air water cylinder and Air water tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713700 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the device analysis, the Service Repair Technician observed foreign material on the control section, forceps channel port, and grip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668787 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570617 ↗MalfunctionSep 2, 2026Output Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570055 ↗MalfunctionAug 31, 2026Microbial Contamination of Device
It was reported that, during reprocessing, the colonovideoscope exceeded the acceptance threshold for aerobic mesophilic bacteria, and the residual protein content exceeded the allowable limits in both the Air-Water channel and the Aquajet/Albarran lever channel. All channels were sampled. The user did not report any contamination or any other serious deterioration in the 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 50524845 ↗MalfunctionAug 31, 2026Failure to Clean Adequately
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521360 ↗MalfunctionAug 31, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520805 ↗MalfunctionAug 26, 2026No Display/Image; Communication or Transmission Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464967 ↗MalfunctionAug 18, 2026Contamination; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299775 ↗MalfunctionAug 17, 2026Residue After Decontamination; Communication or Transmission Problem
The customer reported that the colonovideoscope displayed scope communication error E215 during inspection prior to use. During the initial evaluation of the device, it was observed that the cable unit was dirty, and foreign objects were present on the nozzle and C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277353 ↗MalfunctionAug 13, 2026Device Reprocessing Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50242048 ↗MalfunctionAug 10, 2026Image Display Error/Artifact
The customer reported artifact on the screen, screen displayed interference and the image intermittently disappeared during Needle Knife Cut therapeutic procedure involving an Olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196164 ↗MalfunctionAug 10, 2026Communication or Transmission Problem
The customer reported the colonovideoscope displayed scope communication error (B30 and E216) during inspection prior to use. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190353 ↗MalfunctionAug 7, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for evaluation related to a separate issue. During testing the repair center technician found foreign material on c cover, cause not identified. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183333 ↗
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-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- 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-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
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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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