EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190L (REF N3802140)Recalls & reported problems
Olympus Medical Systems Corp. · CF-HQ190L EVIS EXERA III HD COLONOSCOPE · Class 2
All models of EVIS EXERA lll COLONOVIDEOSCOPE (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III colonoscope is a flexible scope. Of its 6,629 reports, 2 describe deaths and 102 describe injuries; many describe scopes that did not clean adequately or had communication problems. Reports rose from 669 in the prior year to 4,336 in the latest year. There are 3 open recalls, covering repairs made without adhesive and a drying step that left some scopes wet inside.
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
- 6,804
- Deaths reported
- 2
- Injuries reported
- 101
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 6,804 adverse event reports that list this exact device (DI 04953170305115), received between May 11, 2018 and Sep 30, 2026 — classified as 2 deaths, 101 injuries, 6,701 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (2,695 reports).
3 FDA recall records name this device's identifier, 3 still open.
7 other recalls cover devices cleared under the same FDA submission (K131780); 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
Recalls naming this device
- Jan 11, 2024Class IIOpen, Classified
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1207-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Oct 16, 2023Class IIOpen, Classified
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Z-0415-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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 Adequately2,695
- Communication or Transmission Problem1,121
- No Display/Image751
- Device Reprocessing Problem595
- Poor Quality Image575
- Microbial Contamination of Device446
- Residue After Decontamination393
- Erratic or Intermittent Display202
Patient problems
- No Clinical Signs, Symptoms or Conditions6,602
- No Consequences Or Impact To Patient58
- No Known Impact Or Consequence To Patient51
- Bowel Perforation24
- No Patient Involvement15
- Hemorrhage/Blood Loss/Bleeding13
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
Recent adverse event reports
The 25 most recent of 6,804 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953468 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953192 ↗MalfunctionSep 30, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953005 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952662 ↗MalfunctionSep 30, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951586 ↗MalfunctionSep 30, 2026Poor Quality Image
The customer reported a fuzzy image with white specks during the pre-use inspection of an Olympus Colonovideoscope. During the initial device evaluation, a noisy image condition was confirmed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950819 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
The customer reported the videoscope experienced error code B30 during set up / inspection for use. During the initial evaluation of the device it was observed that there was no image. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950026 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue at air water channel, cylinder and auxiliary water channel was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948946 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display
It was reported that during a therapeutic colonoscopy, the colonovideoscope's monitor image blacked out for 1-5 seconds. The procedure was completed using the same device.During the initial device evaluation, the scope's image was flickering. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948758 ↗MalfunctionSep 30, 2026Crack
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, a cracked light guide lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948187 ↗MalfunctionSep 30, 2026Contamination; No Display/Image; Connection Problem
The customer reported that the Colonovideoscope displayed no video output during a diagnostic colonoscopy while the patient was sedated and the device was in use. Upon connection, the image would briefly appear before the image shut off. The procedure was completed using the same device.During the initial evaluation of the device, it was observed there was an error code E216. In addition, it was also noted there was white residue inside the air / water (A/W) channel and inside the auxiliary water flow. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948165 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the device, white foreign materials in air water channel and cylinder was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947967 ↗MalfunctionSep 30, 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 channel and cylinder was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947944 ↗MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947848 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
The customer reported scope communication error E226 during an inspection for use involving an Olympus colonovideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947812 ↗MalfunctionSep 30, 2026No Display/Image
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, no imagewas observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947505 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
The customer reported the colonovideoscope had to clean the contact of scope connector and it still did not work during inspection for use. During the initial evaluation of the device, no image was observed. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945435 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
The customer reported the colonovideoscope had communication error. During the initial evaluation of the device, no image and error code B30 (Scope communication error) were observed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942378 ↗MalfunctionSep 30, 2026Residue After Decontamination
During onsite inspection of the colonovideoscope, residue was found at Air Water channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941959 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, foreign objects were observed coming out of the distal end (nozzle) and the air water cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941713 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer reported that the colonovideoscope had a separate issue. During the initial evaluation of the returned device, foreign material was observed in the air/water channel, cylinder, and auxiliary channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941664 ↗MalfunctionSep 29, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941041 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939943 ↗MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938241 ↗MalfunctionSep 29, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938197 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.
- Z-1210-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0341-2024 · Sep 25, 2023 · Open, ClassifiedColonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
- Z-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil
Other Colonoscope and accessories, flexible/rigid devices
- 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
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 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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