COLONOVIDEOSCOPE OLYMPUS CF-EZ1500D SERIES (REF N6022540)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 colonovideoscope is a flexible scope used to view the large intestine. Its 92 reports, with no injuries and no deaths, describe communication problems, no display or image, and cleaning residue after decontamination. Most reports describe no clinical signs in patients. No recalls name this device. Reports for the last 12 months (91) are far more than in the previous 12 months (1).
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
- 102
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04953170425158), received between Oct 16, 2025 and Sep 29, 2026 — classified as 102 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (43 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
- Communication or Transmission Problem43
- Failure to Clean Adequately27
- No Display/Image17
- Residue After Decontamination8
- Erratic or Intermittent Display4
- Poor Quality Image4
- Connection Problem3
- Overheating of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions100
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940796 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933517 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925990 ↗MalfunctionSep 28, 2026Erratic or Intermittent Display
The customer reported the device kept freezing unexpectedly during a diagnostic colonoscopy procedure involving an Olympus colonovideoscope while the patient was under sedation. The intended procedure was completed using a similar device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923842 ↗MalfunctionSep 28, 2026No Display/Image
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, no connection and no image were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917610 ↗MalfunctionSep 28, 2026No Display/Image
The customer reported screen turns black involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917344 ↗MalfunctionSep 24, 2026No Display/Image
The customer reported not captured 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 50888720 ↗MalfunctionSep 23, 2026Poor Quality Image; Communication or Transmission Problem
The customer reported the colonovideoscope had error code E315 (Incompatible scope) during inspection for use. During the initial evaluation of the device, static image was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869863 ↗MalfunctionSep 22, 2026Use of Device Problem
An Olympus Endoscopy Support Specialist (ESS) has been dispatched to observe the user facility¿s and during the observation reported Use of a non-water-soluble additive was employed via the auxiliary water channel during a Diagnostic Colonoscopy completed with the same device involving an Olympus Colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855256 ↗MalfunctionSep 14, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for a separate issue. During the device analysis, the technical assistance indicates that a white residue inside air water supply was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763048 ↗MalfunctionSep 9, 2026Failure to Clean Adequately
The customer reported white material oozing from a seam in the control body, located in the horizontal seam below the control knobs on the handle, during inspection for use involving an Olympus Colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690155 ↗MalfunctionSep 3, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50597691 ↗MalfunctionAug 31, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523392 ↗MalfunctionAug 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509737 ↗MalfunctionAug 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50505849 ↗MalfunctionAug 28, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496926 ↗MalfunctionAug 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50489000 ↗MalfunctionAug 27, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465252 ↗MalfunctionAug 26, 2026No Display/Image
The customer returned the Colonovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates that no image was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50443658 ↗MalfunctionAug 25, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, a white residue was observed in the air water supply and the auxiliary water flow. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435647 ↗MalfunctionAug 25, 2026Communication or Transmission Problem
The customer reported the Olympus Colonovideoscope had code 315 (incompatible scope) scope detection failure during inspection for use. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50426772 ↗MalfunctionAug 25, 2026Communication or Transmission Problem
The customer returned the Colonovideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician observed that Error 277 had occurred. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50425090 ↗MalfunctionAug 24, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420433 ↗MalfunctionAug 20, 2026No Display/Image; Communication or Transmission Problem; Output Problem
The customer reported no light, no image and error communicated code e227 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 50334984 ↗MalfunctionAug 18, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290418 ↗
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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