EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190L (REF N3802341)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 colonoscope has 95 adverse event reports, including 94 malfunctions and one injury, with no deaths. Reports mostly describe reprocessing and cleaning problems, microbial contamination, processor communication errors, and poor or missing images. Reports were 23 in the last 12 months versus 1 in the prior 12 months. No recalls name this device.
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
- 99
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 04953170436611), received between Jun 26, 2023 and Sep 24, 2026 — classified as 1 injury, 98 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (45 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 Adequately45
- Microbial Contamination of Device21
- Communication or Transmission Problem11
- No Display/Image7
- Poor Quality Image7
- Device Reprocessing Problem4
- Corroded3
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
- Unspecified Gastrointestinal Problem1
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026No Display/Image
The customer reported that the equipment did not display an image during an unspecified procedure involving an Olympus Colonovideoscope. The customer suspected that the cause of the equipment not displaying an image was due to fluid invasion. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877153 ↗MalfunctionSep 21, 2026Material Protrusion/Extrusion
The customer reported exposed needle passage in the working channel during an unspecified procedure involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846612 ↗MalfunctionSep 8, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678953 ↗MalfunctionSep 8, 2026Poor Quality Image
The customer reported color streaks on the screen during inspection for use involving an Olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671518 ↗MalfunctionJun 9, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED NO COMMUNICATION WITH PROCESSOR ALONG AND AN E315 ERROR (INCOMPATIBLE SCOPE ERROR) E315 DURING INSPECTION FOR USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444751 ↗MalfunctionJun 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT FOREIGN OBJECTS INSIDE THE JET TUBE, SUCTION CYLINDER, AND RESIDUAL LIQUID OR FOREIGN MATERIAL CAME OUT OF THE CHANNEL TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436949 ↗MalfunctionJun 4, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD CORROSION IN THE AIR/WATER COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25398253 ↗MalfunctionMay 25, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD A DISTORTED IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273469 ↗MalfunctionMay 23, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED SCOPE ERROR E217 DURING MAINTENANCE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264915 ↗MalfunctionMay 15, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD ERROR E237. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182336 ↗MalfunctionMay 13, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD A B30 SCOPE COMMUNICATION ERROR. THE EVENT OCCURRED AT INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158784 ↗MalfunctionMay 12, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD DIRT ON THE OBJECTIVE LENS AND CORROSION ON THE SUCTION COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150063 ↗MalfunctionMay 4, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED NO IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070862 ↗MalfunctionApr 21, 2026Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED BURN ON C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938253 ↗MalfunctionApr 1, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD IMAGE DISTORTION. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WAS A PROCEDURAL DELAY OF LESS THAN THIRTY MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753873 ↗MalfunctionMar 23, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED STICKY SECOND KEY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670671 ↗MalfunctionMar 23, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED INTERFERENCE IN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663609 ↗MalfunctionMar 17, 2026Corroded; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD NO IMAGE AND CORRODE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616317 ↗MalfunctionMar 17, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A FROZEN IMAGE AND IT STARTS RECORDING ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615622 ↗MalfunctionMar 5, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521822 ↗MalfunctionMar 2, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491980 ↗MalfunctionFeb 13, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED B30 SCOPE COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334347 ↗MalfunctionFeb 4, 2026Poor Quality Image; Activation Failure
B5 CORRECTION: THE CUSTOMER REPORTED FAILED TO START UP DURING DIAGNOSTIC PROCEDURE. INVOLVING AN OLYMPUS COLONOVIDEOSCOPE THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257630 ↗MalfunctionDec 30, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927159 ↗MalfunctionDec 30, 2025No Display/Image; Positioning Problem; No Display/Image; Positioning Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE RIGHT/LEFT HANDLE WAS LOCKED AND THE SCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923503 ↗
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-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- 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-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.
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