EVIS EXERA II COLONOVIDEOSCOPE CF-Q165I (UDI 04953170339684)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 camera used to look inside the colon. The 45 reports mostly describe cleaning and reprocessing problems — residue remaining after cleaning, microbes found on the device, and debris inside the air, water and forceps channels — along with a few image quality and corrosion issues. All were found in the device itself; no deaths or injuries are reported. There are no recalls naming this device. Reports have risen sharply, from 5 in the prior12 months to 16 in the last 12.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170339684), received between Jul 12, 2019 and Sep 17, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (19 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 Adequately19
- Device Reprocessing Problem10
- Microbial Contamination of Device10
- Poor Quality Image3
- Corroded2
- Break1
- Contamination1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810083 ↗MalfunctionAug 26, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461261 ↗MalfunctionAug 6, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164665 ↗MalfunctionJul 31, 2026Melted; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101781 ↗MalfunctionJul 10, 2026Output Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN NOTED THAT NO ILLUMINATION WAS OBTAINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782127 ↗MalfunctionJun 15, 2026Poor Quality Image; Failure to Clean Adequately
THE CUSTOMER RETURNED COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, SERVICE REPAIR TECHNICIAN INDICATED THAT A GRIP, PLASTIC DISTAL END COVER, RIGHT LEFT AND UPWARD DOWNWARD ANGULATION CONTROL KNOB, CONNECTING TUBE HAS FOREIGN MATERIAL AND NOISE OCCUR IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511337 ↗MalfunctionMay 14, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176617 ↗MalfunctionApr 21, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN WHITE MATERIAL IN THE AIR AND WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942294 ↗MalfunctionApr 11, 2026Device Reprocessing Problem; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE AIR -WATER CYLINDER AND AIR-WATER TUBE HAD WHITE FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845997 ↗MalfunctionApr 10, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844501 ↗MalfunctionApr 9, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT, DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE C-COVER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831354 ↗MalfunctionApr 2, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE COLONOVIDEOSCOPE HAD CORROSION IN DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765660 ↗MalfunctionFeb 27, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN LIGHT GUIDE ROD LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476524 ↗MalfunctionFeb 3, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL AT THE C-COVER, SWITCH 1, BENDING SECTION COVER AND FORCEPS CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246275 ↗MalfunctionJan 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197488 ↗MalfunctionJan 16, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED GRAINY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092566 ↗MalfunctionJan 8, 2026Device Reprocessing Problem
IT WAS OBSERVED DURING DEVICE EVALUATION OF THE COLONOVIDEOSCOPE, THE AIR/ WATER (A/W) CHANNEL, A\W CYLINDER HAD WHITE FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24015451 ↗MalfunctionOct 16, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN LIGHT GUIDE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312869 ↗MalfunctionJun 19, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT DURING REPROCESSING THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL FORM THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22291980 ↗MalfunctionMay 19, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNKNOWN NUMBER OF COLONY FORMING UNITS (CFUS) OF STENOTROPHOMONAS MALTOPHILIA AND TESTED POSITIVE FOR >60 (CFUS) OF AEROBIC MICRO-ORGANISMS AT 30° C. 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 22045962 ↗MalfunctionMay 19, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045547 ↗MalfunctionJan 24, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21236088 ↗MalfunctionOct 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464937 ↗MalfunctionOct 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391061 ↗MalfunctionSep 27, 2024Failure to Clean Adequately; Failure to Clean Adequately
THE REPORTABLE EVALUATION FINDING OF THE PLASTIC DISTAL END COVER HAD FOREIGN OBJECTS WAS FOUND ON (B)(6) 2024. G3 IN THE MEDWATCH UPDATED TO REFLECT THE REPORTABLE FINDING DATE BASED ON EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20317868 ↗
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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