COLONOVIDEOSCOPE CF-Q150L (UDI 04953170229466)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of COLONOVIDEOSCOPE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus CF-Q150L colonoscope is a flexible camera used to examine the colon. Most of its 30 reports describe image quality problems, cleaning and reprocessing issues, and no image display at all, with several problems found during service checks rather than during a procedure. No deaths or injuries are described. There are no recalls naming 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04953170229466), received between Jan 10, 2023 and Sep 28, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (10 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
- Poor Quality Image10
- Failure to Clean Adequately6
- Device Reprocessing Problem2
- No Display/Image2
- Contamination1
- Contamination /Decontamination Problem1
- Corroded1
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Poor Quality Image
The customer reported that the banding in the image was displayed involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917913 ↗MalfunctionJun 8, 2026Material Protrusion/Extrusion
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT INSERTION TUBE HAD A PROTRUSION WAS FOUND. IT WAS DETERMINED THAT THE INSERTION TUBE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428972 ↗MalfunctionJun 1, 2026Melted
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATED THE LIGHT FIBER ON ENDOSCOPE TUBE SECTION HAD A BURN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25346374 ↗MalfunctionMay 23, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD ARTIFACTS IN THE IMAGE. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264964 ↗MalfunctionMay 21, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE HAD WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF WEAK SUCTION OCCURS. PROBLEM WITH AIR WATER FLOW OR ASPIRATION SYSTEM. THIS DOES NOT INDICATE A MEDICAL DEVICE REPORTABLE EVENT. HOWEVER, MEDICAL DEVICE REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FOREIGN OBJECT STUCK IN SUCTION CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247324 ↗MalfunctionMay 18, 2026Poor Quality Image
IT WAS REPORTED THE COLONOVIDEOSCOPE PRODUCED POOR IMAGE QUALITY (INTERFERENCE). THIS ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200303 ↗MalfunctionMay 11, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD OBJECT OR ARTIFACTS IN THE IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136949 ↗MalfunctionMay 11, 2026Image Display Error/Artifact
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD ARTIFACTS IN THE IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136670 ↗MalfunctionApr 9, 2026Poor Quality Image
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD IMAGE INTERFERENCE (IMAGE STAINED). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831304 ↗MalfunctionApr 1, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE FOLLOWING REPORTABLE EVENT: WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751687 ↗MalfunctionMar 30, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717400 ↗MalfunctionMar 18, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED BLACK SCREEN WITH NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634739 ↗MalfunctionMar 18, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION ON OBJECTIVE LENS AND INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627709 ↗MalfunctionMar 17, 2026Physical Resistance/Sticking
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED STICKY INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619978 ↗MalfunctionMar 17, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617251 ↗MalfunctionFeb 10, 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 24301502 ↗MalfunctionJan 12, 2026Poor Quality Image
IT WAS REPORTED THE COLONOVIDEOSCOPE DISPLAYED INTERFERENCE IN THE IMAGE. THIS WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048051 ↗MalfunctionDec 28, 2025Failure to Clean Adequately; Failure to Clean Adequately
NO NEW INFORMATION PROVIDED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903377 ↗MalfunctionDec 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS FOUND TO HAVE RESIDUE ON DISTAL TIP AND BIOPSY CHANNEL OUTLET. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882921 ↗MalfunctionNov 18, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586654 ↗MalfunctionNov 14, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXPERIENCED INTERFERENCE IN THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554811 ↗MalfunctionOct 31, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435983 ↗MalfunctionJul 17, 2025Degraded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONO VIDEOSCOPE EXHIBITED A CORRODED NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538310 ↗MalfunctionJul 1, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT HAD CONTAMINATED MOUNT, ASPIRATION HOUSING AND SIDE COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372468 ↗MalfunctionNov 14, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL EXITING FROM THE AIR/WATER NOZZLE OF THE SUBJECT DEVICE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685250 ↗
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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