COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DLRecalls & 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 colonoscope is a flexible scope used for bowel exams. Its 825 reports include 12 injuries and no deaths. Many describe the scope not being cleaned adequately, with white residue left in its air and water channels, and some describe communication or display problems. Reports rose to 576 in the last 12 months, up from 63 in the 12 months 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
- 859
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 859 adverse event reports that list this exact device (DI 04953170424281), received between Jun 21, 2023 and Sep 29, 2026 — classified as 9 injuries, 850 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (431 reports).
1 other recall cover devices cleared under the same FDA submission (K222584); they may or may not involve this specific model.
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 Adequately431
- Communication or Transmission Problem147
- No Display/Image77
- Residue After Decontamination76
- Poor Quality Image48
- Device Reprocessing Problem45
- Microbial Contamination of Device19
- Erratic or Intermittent Display18
Patient problems
- No Clinical Signs, Symptoms or Conditions852
- Abdominal Pain5
- Ascites5
- Intra-Abdominal Hemorrhage5
- Nausea5
- Fungal Infection2
Recent adverse event reports
The 25 most recent of 859 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Complete Blockage; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938325 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Communication or Transmission Problem
The customer reported scope communication error and scrambled screen 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 50933397 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, Residue on objective lens observed, No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916009 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914910 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, a borescope found a foreign substance in the forceps passage channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913745 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white debris was observed on the nozzle, and white residue was observed inside the air/water supply channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912872 ↗MalfunctionSep 25, 2026Microbial Contamination of Device
It was reported that the Colonovideoscope tested positive for an unexpected contamination. The issue was found during a routine culture of the scope. The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897663 ↗MalfunctionSep 24, 2026Residue After Decontamination
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the white residue in air water channel and cylinder was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881902 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876499 ↗MalfunctionSep 23, 2026No Display/Image; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874106 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer reported an error code during an inspection for use involving an Olympus Colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868521 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, a scope communication error (Error Code E216) was noted. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868351 ↗MalfunctionSep 23, 2026Device Reprocessing Problem
The customer reported that the colonovideoscope was unable to pass a residue test and could not be sterilized properly during reprocessing. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866800 ↗MalfunctionSep 22, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861852 ↗MalfunctionSep 22, 2026No Display/Image
The customer returned the Colonovideoscope to the service center for a separate issue. During device analysis, the Service Repair Technician reported that no image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857986 ↗MalfunctionSep 21, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847375 ↗MalfunctionSep 21, 2026Device Reprocessing Problem
The customer returned the Colonovideoscope to the service center for a separate issue. During device analysis, the Service Repair Technician reported white residue in the air/water supply channel and on the cylinder side. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847112 ↗MalfunctionSep 21, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839179 ↗MalfunctionSep 17, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797059 ↗MalfunctionSep 16, 2026Corroded; No Display/Image; Communication or Transmission Problem
The customer reported the colonovideoscope no image during a inspection for use. During the initial evaluation of the device it was observed, scope communication error B30 and Printed circuit board and Charged coupled device due to heavy fluid that caused corrosion. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789565 ↗MalfunctionSep 14, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device white residue inside air water channel and Cylinder alongside with white residue in auxiliary water tube was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50750380 ↗MalfunctionSep 11, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736532 ↗MalfunctionSep 10, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722642 ↗MalfunctionSep 10, 2026No Display/Image; Communication or Transmission Problem
The customer returned the colon videoscope for a separate issue. During the initial evaluation of the returned device, it was observed that no image was displayed, the screen was black, and a scope communication error (B30) was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717068 ↗MalfunctionSep 9, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698729 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K222584. One submission often covers many models, so check the product and lot details in each record.
- Z-0181-2025 · Aug 21, 2024 · Open, ClassifiedOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
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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