EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190L (REF N3802141)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
Quick summary
This Olympus EVIS EXERA III colonoscope has 249 reports on file, with no deaths and 7 injuries. Many describe the scope failing to clean adequately after reprocessing, and others describe no image, a black screen, noisy images or dirt on the lens. A few patient problems include lacerations, bleeding and a bowel perforation. No recalls name this device, and reports rose to 49 in the latest year from 15 in the year before.
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
- 250
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 04953170436574), received between May 9, 2023 and Sep 24, 2026 — classified as 7 injuries, 243 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (149 reports).
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
Most reported problems
Device problems
- Failure to Clean Adequately149
- Device Reprocessing Problem22
- No Display/Image18
- Communication or Transmission Problem17
- Poor Quality Image10
- Microbial Contamination of Device8
- Thermal Decomposition of Device6
- Mechanical Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions246
- Laceration(s)3
- Hematoma2
- Bowel Perforation1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Clean Adequately
The customer reported the Colonovideoscope objective and light lenses, and the light guide cap were dirty. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889492 ↗MalfunctionSep 18, 2026No Display/Image
The customer reported the colonovideoscope had no iamge during service maintenance. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813902 ↗MalfunctionSep 16, 2026No Display/Image; Communication or Transmission Problem
It was reported that the colonovideoscope had no image and it Does not recognize the processor. The issue was found during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789286 ↗MalfunctionAug 31, 2026Erratic or Intermittent Display; No Display/Image
The customer returned the colonovideoscope to the service center for evaluation related to a separate issue. During inspection, the Service Repair Technician identified that the device had displayed no image and a black screen occurs intermittently. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524642 ↗MalfunctionJul 28, 2026No Display/Image
The customer reported no image involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062080 ↗MalfunctionJul 20, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25871631 ↗MalfunctionJun 27, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A COMMAND SLACK. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT A NOISY IMAGE WAS FOUND. IT WAS DETERMINED THAT THE CHARGED COUPLED DEVICE UNIT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646077 ↗MalfunctionJun 24, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE TECHNICIAN, INDICATES THAT A NOISY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608860 ↗MalfunctionJun 18, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT DIRT ON THE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552392 ↗MalfunctionJun 1, 2026No Display/Image
IT WAS REPORTED THAT NO IMAGE APPEARED ON THE COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355814 ↗MalfunctionMay 27, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT DIRT ON THE OBJECTIVE LENS WAS FOUND. IT WAS DETERMINED THAT THE OBJECTIVE LENS NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25296515 ↗MalfunctionMay 22, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257747 ↗MalfunctionMay 18, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE IS NOT DISPLAYING AN IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203833 ↗MalfunctionMay 18, 2026Communication or Transmission Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD A CONNECTION ERROR, AND THE PROCESSOR DID NOT RECOGNIZE IT. THE ISSUE OCCURRED DURING THE REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203760 ↗MalfunctionMay 18, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS NOT DISPLAYING IMAGES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202801 ↗MalfunctionMay 13, 2026Degraded; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE DISPLAYED A B30 ERROR, RUSTED CONNECTOR BLOCK, AND A NO IMAGE ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160626 ↗MalfunctionMay 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A DIRTY LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123935 ↗MalfunctionApr 20, 2026Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A BURN ON THE C COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926290 ↗MalfunctionApr 20, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A BURNT DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924757 ↗MalfunctionApr 17, 2026Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911603 ↗MalfunctionApr 16, 2026Flare or Flash
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD A BURN ON THE COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24894669 ↗MalfunctionApr 7, 2026Positioning Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD A LOCKING MOVEMENT ISSUE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24807746 ↗MalfunctionApr 6, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789283 ↗MalfunctionApr 3, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780613 ↗MalfunctionMar 23, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION AT THE SUCTION COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669933 ↗
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-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L 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-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
- 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page