EVIS EXERA II COLONOVIDEOSCOPE CF-Q165I (UDI 04953170202537)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 scope used for colon examinations. Many of the 126 reports describe the scope not being cleaned adequately, microbial contamination, or problems with cleaning and disinfection. The reports include no deaths and 3 injuries. Reports rose to 41 in the last 12 months from 18 in the previous 12. 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
- 127
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 04953170202537), received between May 23, 2018 and Sep 24, 2026 — classified as 3 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (53 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 Adequately53
- Microbial Contamination of Device26
- Device Reprocessing Problem19
- Corroded10
- No Display/Image4
- Poor Quality Image4
- Adverse Event Without Identified Device or Use Problem3
- Erratic or Intermittent Display3
Patient problems
- No Clinical Signs, Symptoms or Conditions106
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient4
- Hemorrhage/Blood Loss/Bleeding2
- Bowel Perforation1
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889734 ↗MalfunctionSep 14, 2026Failure to Clean Adequately
The customer returned colonovideoscope to the service center for a separate issue. During the device analysis, the service center identified that the device exhibited C-cover and Nozzle has foreign objects was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754915 ↗MalfunctionSep 11, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732845 ↗MalfunctionAug 26, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455891 ↗MalfunctionAug 14, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261328 ↗MalfunctionAug 14, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260014 ↗MalfunctionAug 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213627 ↗MalfunctionAug 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213220 ↗MalfunctionAug 11, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201372 ↗MalfunctionJul 30, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082988 ↗MalfunctionJul 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075687 ↗MalfunctionJul 10, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE NOZZLE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25784955 ↗MalfunctionJul 6, 2026Corroded
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, LIGHT GUIDE LENS HAS CORROSION. 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 25716055 ↗MalfunctionJun 27, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A CRUSHED DISTAL END. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT A FOREIGN MATERIAL ON GRIP, CONTROL SECTION, SCOPE COVER, JET TUBE (WHITE FOREIGN MATERIAL, LIGHT GUIDE LENS AND C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646075 ↗MalfunctionJun 12, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, THE AIR WATER CYLINDER AND TUBE CONTAINED FOREIGN OBJECTS. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490925 ↗MalfunctionJun 11, 2026Device Reprocessing Problem; Obstruction of Flow; Failure to Clean Adequately
IT WAS REPORTED THAT COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE CHANNEL. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477449 ↗MalfunctionJun 2, 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 WHITE FOREIGN MATERIAL IN AIR/WATER CHANNEL AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360791 ↗MalfunctionMay 20, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION IN AIR WATER CYLINDER AND IN DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231244 ↗MalfunctionMay 18, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS COME OUT OF DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203483 ↗MalfunctionMay 14, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE SCOPE COVER CASE UNIT AND CORRODED C-COVER, LIGHT GUIDE COVER GLASS, FORCEPS CHANNEL PORT, SUCTION CYLINDER AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176518 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED J-TUBE (AUXILIARY WATER CHANNEL TUBE) HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149721 ↗MalfunctionApr 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE PLASTIC DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024152 ↗MalfunctionApr 24, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD CORRODED AIR/WATER CYLINDER, FORCEPS ELEVATOR LEVER AND FOREIGN OBJECTS IN THE C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980448 ↗MalfunctionApr 23, 2026Erratic or Intermittent Display
IT WAS REPORTED THE COLONOVIDEOSCOPE WAS NOT WORKING THE SCREEN ONLY DISPLAYED LINES AND DOTS. THE ISSUE OCCURRED DURING A PRE PROCEDURE CHECK ANNO PROCEDURE HAD BEGUN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968318 ↗MalfunctionApr 20, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS AT THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934006 ↗
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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