EVIS EXERA II COLONOVIDEOSCOPE CF-Q165L (UDI 04953170202476)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 has 177 adverse event reports, with no deaths and 2 injuries. The reports mostly describe the scope not being cleaned adequately, poor image quality, and cleaning and disinfection problems, with some reporting microbial contamination and corrosion. No recalls name this device, and reports rose to 85 in the latest 12 months from 30 in the prior 12 months.
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
- 184
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 04953170202476), received between Jul 14, 2020 and Sep 30, 2026 — classified as 2 injuries, 182 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (93 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 Adequately93
- Poor Quality Image22
- Device Reprocessing Problem18
- No Display/Image17
- Microbial Contamination of Device13
- Corroded6
- Erratic or Intermittent Display5
- Overheating of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions181
- Hemorrhage/Blood Loss/Bleeding2
- No Known Impact Or Consequence To Patient1
- Unspecified Gastrointestinal Problem1
Recent adverse event reports
The 25 most recent of 184 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign material on scope cover and light guide lens were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951367 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer reported that dark black liquid was leaking from the working channel of an olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948381 ↗MalfunctionSep 24, 2026Corroded; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892354 ↗MalfunctionSep 24, 2026No Display/Image
The customer reported that no image was visible during inspection prior to use involving an Olympus colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880729 ↗MalfunctionSep 23, 2026Device Reprocessing Problem
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the foreign objects at control section and scope connector was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870611 ↗MalfunctionSep 23, 2026No Display/Image
The customer reported that the device did not capture an image involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863503 ↗MalfunctionSep 17, 2026Erratic or Intermittent Display
The customer reported Interference involving an Olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804510 ↗MalfunctionSep 2, 2026No Display/Image; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572756 ↗MalfunctionSep 1, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554218 ↗MalfunctionAug 14, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256830 ↗MalfunctionAug 14, 2026No Display/Image; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253012 ↗MalfunctionAug 13, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240247 ↗MalfunctionAug 11, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213328 ↗MalfunctionAug 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213266 ↗MalfunctionAug 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212401 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140625 ↗MalfunctionAug 4, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50127496 ↗MalfunctionAug 3, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50120093 ↗MalfunctionAug 3, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116277 ↗MalfunctionJul 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087018 ↗MalfunctionJul 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051433 ↗MalfunctionJul 27, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005544 ↗MalfunctionJul 14, 2026Output Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE REPAIR TECHNICIAN INDICATES THAT NO ILLUMINATION WAS OBTAINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817284 ↗MalfunctionJul 10, 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 IN AIR/WATER TUBE, JET TUBE AND LIGHT GUIDE LENS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782220 ↗MalfunctionJul 9, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT BURNED C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766220 ↗
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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