EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL (UDI 04953170202315)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA II colonoscope is a flexible scope used to examine the colon. Many of the 82 reports describe scopes not being cleaned adequately, reprocessing problems, and images not displaying. The reports include 1 injury and no deaths. There is 1 open recall, from December 2022, after a scope was used in a veterinary procedure by mistake, which could allow microbial contamination.
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
- 83
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 04953170202315), received between Sep 25, 2018 and Sep 3, 2026 — classified as 1 injury, 82 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (35 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 21, 2022Class IIOpen, Classified
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Z-1132-2023 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately35
- Device Reprocessing Problem14
- Microbial Contamination of Device10
- No Display/Image4
- Poor Quality Image4
- Contamination /Decontamination Problem3
- Communication or Transmission Problem2
- Corroded2
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Perforation1
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50586995 ↗MalfunctionJul 3, 2026No Display/Image; Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE EVALUATION, NO IMAGE WAS DISPLAYED, AND FOREIGN OBJECTS WERE OBSERVED ON THE CONNECTING TUBE, GRIP, RIGHT LEFT KNOB, AND FORCEPS ELEVATOR LEVER. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED ALSO FOR THE NO IMAGE WAS DISPLAYED, CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703839 ↗MalfunctionJun 26, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD EMERGENCE OF FOREIGN OBJECT FROM DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641518 ↗MalfunctionMay 20, 2026Device Reprocessing Problem; Corroded
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD A CORRODED SHEET HOLDER UNIT AND IDENTIFICATION COVER, AS WELL AS A DIRTY SHIELD PLATE AND CHARGE-COUPLED DEVICE FLEXIBLE PRINTED CIRCUIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237034 ↗MalfunctionMay 19, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD A FOREIGN BODY (WHITE FOREIGN MATERIAL) IN THE WATER/AIR CHANNEL (TUBE) AND A FOREIGN OBJECT (WHITE FOREIGN MATERIAL) IN THE AIR/WATER VALVE SOCKET (TUBE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222829 ↗MalfunctionMay 15, 2026Erratic or Intermittent Display
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE EXHIBITED A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191032 ↗MalfunctionMay 3, 2026Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063069 ↗MalfunctionApr 29, 2026No Display/Image
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD APPEARED NO IMAGE ON THE PROCESSOR. THE ISSUE WAS IDENTIFIED DURING DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032003 ↗MalfunctionApr 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED DIRT ON OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821548 ↗MalfunctionApr 8, 2026Obstruction of Flow
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD AN OBSTRUCTION (DEBRIS) IN THE DIFFUSER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816188 ↗MalfunctionMar 19, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD DIRT ON THE LIGHT GUIDE (LG) ROD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640167 ↗MalfunctionMar 16, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION IN THE SUCTION COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24611634 ↗MalfunctionJan 27, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE LIGHT GUIDE ROD LENS AND A DIRTY CHARGED COUPLED DEVICE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24186466 ↗MalfunctionJan 26, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24175909 ↗MalfunctionJan 7, 2026Device Reprocessing Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD IMAGE FREEZE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991919 ↗MalfunctionDec 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A BURN ON THE COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830102 ↗MalfunctionDec 16, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE'S IMAGE WAS NOT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820912 ↗MalfunctionNov 14, 2025Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A DISTURBED IMAGE WHEN CONNECTOR IS PUSHED. ALSO THE SCOPE CONNECTOR'S PLATE WAS DIRTY DUE TO WATER LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560612 ↗MalfunctionNov 13, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON AIR/WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543583 ↗MalfunctionOct 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED MALFUNCTION DUE TO DAMAGE TO THE CHARGED COUPLED DEVICE (CCD) UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413184 ↗MalfunctionSep 4, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE EVALUATION, THE SUBJECT DEVICE'S LIGHT GUIDE ROD LENS HAD FOREIGN MATERIAL PRESENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964821 ↗MalfunctionAug 12, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISTAL END (LIGHT GUIDE ROD LENS) OF THE SCOPE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787203 ↗MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE AND CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505586 ↗MalfunctionJul 7, 2025Temperature Problem; Temperature Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SCOPE EXHIBITED THE PLASTIC PROBE TIP BURNED/BURNT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412413 ↗MalfunctionMay 27, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088896 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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 · each recall links to the FDA recall notice
- 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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