COLONOVIDEOSCOPE CF-H170LRecalls & 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 has 373 reports, with no deaths and 11 injuries. Many describe poor cleaning, contamination and image problems, and a few list bloodstream infections or bowel perforation. There is 1 recall, open since September 2023, over scopes returned after repair that sometimes held water in the channel, which could lead to infection. Recent reports rose from 34 to 121 compared with the period before.
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
- 377
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 377 adverse event reports that list this exact device (DI 04953170334160), received between Jan 16, 2020 and Sep 24, 2026 — classified as 11 injuries, 366 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (192 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 Adequately192
- Contamination37
- Device Reprocessing Problem36
- No Display/Image23
- Poor Quality Image16
- Communication or Transmission Problem15
- Melted14
- Corroded12
Patient problems
- No Clinical Signs, Symptoms or Conditions360
- Bacteremia5
- Granuloma5
- Septic Shock5
- No Consequences Or Impact To Patient4
- Bowel Perforation2
- Bruise/Contusion2
- Perforation2
Recent adverse event reports
The 25 most recent of 377 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Poor Quality Image; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889791 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that residual liquid or foreign material come out of suction cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889035 ↗MalfunctionSep 22, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device foreign objects came out of distal end was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859297 ↗MalfunctionSep 14, 2026Erratic or Intermittent Display
The customer reported image was flickering during inspection for use involving an Olympus colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748089 ↗MalfunctionSep 9, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698864 ↗MalfunctionSep 8, 2026Corroded; Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, the large light guide cover lens was corroded; the control unit showed corrosion and deposits; the grip unit had deposits; the connector exhibited corrosion and deposits; and the light guide cover glass contained dust. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668657 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50527146 ↗MalfunctionAug 31, 2026Flare or Flash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522934 ↗MalfunctionAug 28, 2026Device Reprocessing Problem; Corroded; Crack; No Display/Image; Electrical /Electronic Property Problem; Moisture Damage; Contamination /Decontamination Problem; Communication or Transmission Problem; Environmental Particulates; Positioning Problem; Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504014 ↗MalfunctionAug 25, 2026Failure to Clean Adequately
The customer reported that the Colonovideoscope had foreign material on the lens during preparation for use. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430772 ↗MalfunctionAug 25, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50425722 ↗MalfunctionAug 17, 2026Communication or Transmission Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278219 ↗MalfunctionAug 11, 2026Flare or Flash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216441 ↗MalfunctionAug 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113627 ↗MalfunctionJul 29, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50066588 ↗MalfunctionJul 27, 2026Melted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022562 ↗MalfunctionJul 13, 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 A FOREIGN MATERIAL IN NOZZLE AND DISTAL END WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797312 ↗MalfunctionJul 10, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT TRACES OF BURN ON THE C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 25782666 ↗MalfunctionJul 6, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT BURN ON C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25724735 ↗MalfunctionJun 30, 2026Failure to Clean Adequately
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 FOREIGN OBJECTS AT FORCEPS CHANNEL PORT, AND CORROSION AT AIR WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670596 ↗MalfunctionJun 27, 2026Corroded
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, CORROSION ON CONNECTING TUBE. 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 25646161 ↗MalfunctionJun 23, 2026Corroded
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT C-COVER HAD CORROSION WAS FOUND. IT WAS DETERMINED THAT THE C-COVER NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599696 ↗MalfunctionJun 22, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT RESIDUAL LIQUID OR FOREIGN MATERIAL WAS FOUND COMING OUT OF THE SUCTION CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586075 ↗MalfunctionJun 22, 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 OBSERVED THAT FOREIGN MATERIAL WAS DISCHARGED FROM THE DISTAL END OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25585372 ↗MalfunctionJun 17, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT DIRTY C-COVER, CONTROL UNIT, SCOPE COVER, UP/DOWN, LEFT/ RIGHT KNOBS, CONNECTOR AND LIGHT GUIDE COVER GLASS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535429 ↗
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.
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