EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190L (REF N3802340)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA lll COLONOVIDEOSCOPE (16)
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 EVIS EXERA III colonoscope is a flexible scope used to look inside the colon. Many of its 1,173 reports describe the scope not being cleaned adequately or showing microbial contamination, and others describe image and communication problems. The reports include 1 death and 6 injuries. One recall is open, from September 2023, over scopes returned after repair that could still hold water in the channel. Reports rose from 193 in the previous 12 months to 439 in the last 12 months.
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
- 1,194
- Deaths reported
- 1
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,194 adverse event reports that list this exact device (DI 04953170305153), received between Jun 25, 2018 and Sep 30, 2026 — classified as 1 death, 6 injuries, 1,187 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (539 reports).
1 FDA recall record name this device's identifier, 1 still open.
8 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
- 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 Adequately539
- Microbial Contamination of Device247
- Device Reprocessing Problem100
- Communication or Transmission Problem92
- No Display/Image92
- Poor Quality Image39
- Contamination28
- Corroded24
Patient problems
- No Clinical Signs, Symptoms or Conditions1,132
- No Known Impact Or Consequence To Patient37
- No Consequences Or Impact To Patient17
- Insufficient Information5
- Bowel Burn2
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
Recent adverse event reports
The 25 most recent of 1,194 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949914 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the air water cylinder and tube had foreign objects. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927440 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During initial evaluation of the returned device, it was found that air water tube had foreign material. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899430 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects were observed in the air/water tube and air/water cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896987 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
During onsite inspection of colonovideoscope, it was found foreign objects inside the air water tube and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893006 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the device, foreign objects were observed on the jet tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886270 ↗MalfunctionSep 24, 2026Image Display Error/Artifact
The customer returned the Colonovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, image interference was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885084 ↗MalfunctionSep 24, 2026Overheating of Device
The customer reported that the colonovideoscope had a separate issue. During the initial evaluation of the device, a burn was observed on the C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884572 ↗MalfunctionSep 24, 2026Device Reprocessing Problem
The customer reported that the colonovideoscope had a separate issue. During the initial evaluation of the device, foreign objects were observed in the control section. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884261 ↗MalfunctionSep 21, 2026Overheating of Device
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device, burn mark at light guide lens was observed. The Service Repair Technician indicated that the most likely cause of the burn mark at light guide lens was due to component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841511 ↗MalfunctionSep 18, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the light guide cover glass was sticky. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813991 ↗MalfunctionSep 17, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811839 ↗MalfunctionSep 17, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810164 ↗MalfunctionSep 17, 2026Device Reprocessing Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the device, it was observed that universal cord, connecting tube, distal sheath, air/water cylinder, scope connector cover unit and scope connector case unit had foreign objects. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809392 ↗MalfunctionSep 17, 2026Microbial Contamination of Device
It was reported that, during reprocessing, the scope tested positive for 76 total Colony Forming Units (CFUs) of the following microbes: Enterobacter cloacae complex, Citrobacter amalonaticus, Acinetobacter baumannii and Pseudomonas aeruginosa. All channels were sampled. 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 50808636 ↗MalfunctionSep 14, 2026No Display/Image
During onsite inspection of colonovideoscope, it was found no image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752736 ↗MalfunctionSep 14, 2026Poor Quality Image; Failure to Clean Adequately
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device repair technician found foreign material on the air water tube and air water cylinder, and noise image occurs. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751666 ↗MalfunctionSep 14, 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 foreign matter was observed in the air water cylinder and tube, there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50750632 ↗MalfunctionSep 11, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740935 ↗MalfunctionSep 9, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701840 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer reported a separate issue with the Colonovideoscope. During the initial evaluation of the device, white foreign material was observed in the air/water (A/W) cylinder tube. In addition, residual liquid or foreign material was found coming from the auxiliary water inlet of the endoscope connector, and foreign objects were observed in the scope connector (SC) cover unit. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671888 ↗MalfunctionSep 2, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576505 ↗MalfunctionSep 1, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542910 ↗MalfunctionSep 1, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542143 ↗MalfunctionAug 31, 2026Communication or Transmission Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, scope error (E217) was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531668 ↗
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-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- 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 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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