COLONOVIDEOSCOPE CF-Q150L (UDI 04953170307638)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus colonoscope is a flexible scope used to look inside the large intestine. Its 154 reports mostly describe trouble cleaning the scope, and some describe blank or poor images. The reports include no deaths and 2 injuries, and 152 are malfunctions. The one recall, started in September 2023, is open and concerns scopes that could be returned from repair with a wet channel. Reports rose from 13 in the year before to 61 in the latest year.
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
- 162
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 04953170307638), received between Dec 20, 2021 and Sep 29, 2026 — classified as 2 injuries, 160 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (84 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
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately84
- Poor Quality Image17
- No Display/Image13
- Contamination9
- Corroded9
- Device Reprocessing Problem8
- Erratic or Intermittent Display7
- Residue After Decontamination6
Patient problems
- No Clinical Signs, Symptoms or Conditions159
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Erratic or Intermittent Display; Poor Quality Image
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, intermittent, distorted and noisy image were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937149 ↗MalfunctionSep 24, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890078 ↗MalfunctionSep 18, 2026Poor Quality Image
The customer reported Spotty image during inspection for use involving an Olympus colonovideoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819621 ↗MalfunctionSep 15, 2026Corroded
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, corrosion in the Air/Water cylinder was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777936 ↗MalfunctionSep 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737328 ↗MalfunctionSep 7, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658035 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573399 ↗MalfunctionAug 26, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456344 ↗MalfunctionAug 20, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350258 ↗MalfunctionAug 14, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249188 ↗MalfunctionAug 13, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238679 ↗MalfunctionAug 11, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216282 ↗MalfunctionJul 31, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107361 ↗MalfunctionJul 1, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION OF A SEPARATE ISSUE. DURING TESTING, THE REPAIR CENTER TECHNICIAN FOUND NOISE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680640 ↗MalfunctionJul 1, 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 THAT FOREIGN MATERIAL HAD COME OUT OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680405 ↗MalfunctionJul 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS THE SERVICE CENTER IDENTIFIED CHANNEL TUBE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679812 ↗MalfunctionJun 26, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A BLURRY IMAGE. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT A NOISY IMAGE WAS FOUND. IT WAS DETERMINED THAT THE CHARGED COUPLED DEVICE UNIT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25634800 ↗MalfunctionJun 25, 2026Corroded
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, CORROSION ON SUCTION CYLINDER. 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 25627022 ↗MalfunctionJun 23, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED NOISY AND FLICKERING IMAGE DURING DEVICE INSPECTION FOR USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597897 ↗MalfunctionJun 23, 2026Corroded
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING DEVICE EVALUATION, THE REPAIR CENTER TECHNICIAN IDENTIFIED THE DEVICE HAD CORROSION AT LIGHT GUIDE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597609 ↗MalfunctionJun 23, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT DIRT IN IMAGE FIELD WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596500 ↗MalfunctionMay 23, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF ANGULATION ISSUE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, STICKY SCOPE COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265102 ↗MalfunctionMay 23, 2026Poor Quality Image
THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF AIR NOT COMING. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DISTURBED IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264628 ↗MalfunctionMay 23, 2026No Display/Image
IT WAS REPORTED THE COLONOVIDEOSCOPE EXHIBITED NO VIDEO OUTPUT AND BLACKOUT IMAGE DURING A COLONOVIDEOSCOPY DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264406 ↗MalfunctionMay 21, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITS RESIDUAL FLUID OR FOREIGN MATTER LEAKING FROM THE SCOPE CYLINDER AND FOREIGN OBJECTS IN FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243692 ↗
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 · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page