EVIS EXERA II COLONOVIDEOSCOPE CF-Q165L (UDI 04953170339691)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 for examining the colon. Of its 90 reports, no deaths or injuries are recorded. Reports mostly describe poor cleaning, debris and microbial contamination inside the scope, and image problems. Most reports describe no clinical signs or patient impact. There were 26 reports in the last 12 months, up from 17 before. 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
- 92
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 04953170339691), received between Jul 11, 2018 and Sep 30, 2026 — classified as 92 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (38 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 Adequately38
- Device Reprocessing Problem17
- Microbial Contamination of Device13
- No Display/Image7
- Poor Quality Image6
- Contamination4
- Overheating of Device4
- Corroded2
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- No Known Impact Or Consequence To Patient5
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952875 ↗MalfunctionSep 25, 2026Contamination
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects were observed on the light guide lens. Additionally, the shield plate and disk were found to be dirty. There was no patient involvement.
Patient problems: Insufficient Information
MAUDE report 50898308 ↗MalfunctionAug 28, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500029 ↗MalfunctionJul 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, NOZZLE HAS 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 25683108 ↗MalfunctionMay 29, 2026Corroded
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT CORROSION WAS FOUND ON THE LIGHT GUIDE LENS, THE CAUSE OF WHICH COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336878 ↗MalfunctionMay 8, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION IN THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120505 ↗MalfunctionMay 3, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A NOISY IMAGE, FOREIGN MATERIAL IN THE FORCEPS CHANNEL PORT, AND WHITE FOREIGN MATERIAL IN THE AIR WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063739 ↗MalfunctionMay 3, 2026Communication or Transmission Problem; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN C-COVER, CONNECTING TUBE, FORCEPS CHANNEL PORT AND SCOPE CONNECTOR. NON-COMPATIBLE SCOPE CONNECTION ERROR (E315) WAS ALSO DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062988 ↗MalfunctionApr 22, 2026Complete Blockage; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CLOGGED JET CHANNEL WITH WHITE FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960302 ↗MalfunctionApr 21, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE PRESENTED FOREIGN OBJECTS IN THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941932 ↗MalfunctionMar 25, 2026Obstruction of Flow; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CLOGGED NOZZLE WITH FIBROUS FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688039 ↗MalfunctionMar 23, 2026Device Reprocessing Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD HEAVY RESIDUE ON THE NOZZLE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664485 ↗MalfunctionMar 9, 2026Device Reprocessing Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD BEEN INSUFFICIENTLY REPROCESSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED CONCERNING THIS EVENT, BUT NO RESPONSE HAS BEEN RECEIVED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544935 ↗MalfunctionFeb 23, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A BURNT PLASTIC PROBE TIP AT THE DISTAL TIP OF THE PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414311 ↗MalfunctionFeb 19, 2026No Display/Image; Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387795 ↗MalfunctionFeb 17, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366486 ↗MalfunctionFeb 12, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320256 ↗MalfunctionFeb 11, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317170 ↗MalfunctionFeb 11, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A BURN ON THE LIGHT GUIDE (LG) LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315503 ↗MalfunctionFeb 10, 2026No Display/Image
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD NO IMAGE AVAILABLE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304731 ↗MalfunctionFeb 9, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED JET TUBE WITH FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300822 ↗MalfunctionJan 20, 2026Poor Quality Image
NO NEW INFORMATION PROVIDED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118495 ↗MalfunctionJan 7, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD 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 23988031 ↗MalfunctionJan 6, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PROBE COVER OF THE COLONOVIDEOSCOPE WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973527 ↗MalfunctionDec 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD A DISTORTED IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926366 ↗
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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