EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI (UDI 04953170202506)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II COLONOVIDEOSCOPE (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II colonoscope is a flexible scope used to examine the colon. Its 143 reports mostly describe scopes that could not be cleaned adequately or were found contaminated with microbes, and some mention foreign material inside the scope. There are no deaths and 1 injury. No recalls name this device. Reports rose to 34 in the last 12 months from 19 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
- 145
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 04953170202506), received between May 14, 2018 and Sep 30, 2026 — classified as 1 injury, 144 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (62 reports).
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 Adequately62
- Microbial Contamination of Device47
- Device Reprocessing Problem24
- Contamination4
- Melted4
- Poor Quality Image4
- Corroded3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions119
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient7
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Corroded
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device it was observed, light guide lens has corrosion. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943528 ↗MalfunctionSep 15, 2026Device Reprocessing Problem
The customer returned the colonovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated that Air Water cylinder and tube has foreign objects (white foreign material), Scope cover plate was unclear. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766463 ↗MalfunctionSep 7, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658200 ↗MalfunctionAug 31, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532174 ↗MalfunctionAug 13, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230480 ↗MalfunctionJun 29, 2026Erratic or Intermittent Display; Poor Quality Image
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, IMAGE IS FROZEN, THE IMAGE IS NOT DISPLAYED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660467 ↗MalfunctionJun 29, 2026Device Reprocessing Problem
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 WHITE FOREIGN MATERIAL OBJECTS IN THE AIR/WATER-TUBE, CYLINDER AND JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653940 ↗MalfunctionJun 25, 2026Device Reprocessing Problem
THE CUSTOMER REPORTED AN ERROR MESSAGE, AND THE DEVICE COULD NOT BE DISINFECTED DURING REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630571 ↗MalfunctionJun 22, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR CENTER TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN OBJECTS IN AUXILIARY TUBE (J-TUBE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578955 ↗MalfunctionJun 2, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED 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 25364091 ↗MalfunctionMay 23, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE CENTER IDENTIFIED FOREIGN OBJECTS IN THE JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265154 ↗MalfunctionMay 23, 2026Melted
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD BURN-IN ON THE OPTICS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264818 ↗MalfunctionMay 23, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING TESTING, THE SERVICE CENTER IDENTIFIED THAT THE DEVICE EXHIBITED FOREIGN MATERIAL ON THE DISTAL END COVER, NOZZLE, OBJECTIVE LENS, UNIVERSAL CORD, AND FORCEPS CHANNEL PORT, WHICH ARE CONSIDERED REPORTABLE MALFUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263942 ↗MalfunctionMay 22, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDESCOPE HAD DIRT IN CONTROL UNIT, UNIVERSAL CORD HOLDER, CHARGED COUPLED DEVICE AND ELECTRICAL IDENTIFICATION FLEXIBLE CIRCUIT BOARD, AND HAD FOREIGN OBJECTS IN AIR-WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260215 ↗MalfunctionApr 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN AIR WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020078 ↗MalfunctionApr 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE NOZZLE, ADHESIVE AROUND OBJECTIVE LENS, LIGHT GUIDE LENS, CONNECTING TUBE, AND BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013980 ↗MalfunctionApr 20, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931406 ↗MalfunctionApr 20, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924891 ↗MalfunctionApr 14, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXPERIENCED PICTURE DISTORTION DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873544 ↗MalfunctionApr 10, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR WATER CYLINDER, TUBE AND LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844912 ↗MalfunctionMar 31, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION ON CONNECTING TUBE AND FOREIGN OBJECTS IN AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741605 ↗MalfunctionMar 30, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24726722 ↗MalfunctionMar 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597648 ↗MalfunctionMar 2, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE AIR/WATER CYLINDER, JET TUBE, NOZZLE, CONNECTING TUBE, ADHESIVE AROUND OBJECTIVE LENS, LIGHT GUIDE LENS, AND BENDING RUBBER (A-RUBBER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482386 ↗MalfunctionFeb 18, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A FOREIGN OBJECTS C-COVER, CONNECTING TUBE AND UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378056 ↗
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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