EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190I (REF N3802240)Recalls & reported problems
Olympus Medical Systems Corp. · CF-HQ190I 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
2 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 for colon examinations. Reports most often describe inadequate cleaning and contamination, and reports rose in the last 12 months, to 486 from 250. The FDA database lists 1,298 reports, with 12 injuries and no deaths. The 2 open recalls cover repaired scopes missing a protective adhesive and a drying process that was not validated, which could raise the risk of infection.
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
- 1,315
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,315 adverse event reports that list this exact device (DI 04953170305139), received between Oct 6, 2017 and Sep 30, 2026 — classified as 12 injuries, 1,303 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (750 reports).
2 FDA recall records name this device's identifier, 2 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
- 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-1206-2024 · Root cause: Nonconforming Material/Component · 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 Adequately750
- Device Reprocessing Problem206
- Microbial Contamination of Device171
- Communication or Transmission Problem71
- No Display/Image39
- Poor Quality Image27
- Contamination /Decontamination Problem26
- Contamination25
Patient problems
- No Clinical Signs, Symptoms or Conditions1,259
- No Known Impact Or Consequence To Patient27
- No Consequences Or Impact To Patient21
- Insufficient Information4
- Foreign Body In Patient3
- Bacterial Infection2
- Hemorrhage/Blood Loss/Bleeding2
- Bowel Perforation1
Recent adverse event reports
The 25 most recent of 1,315 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50944749 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938000 ↗MalfunctionSep 29, 2026Device Fell
The customer reported Clip just came off during reprocessing involving an Olympus colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930643 ↗MalfunctionSep 29, 2026Contamination
The customer returned the Colonovideoscope for a separate issue. During the device analysis, the Service Repair Technician observed that white foreign objects were present in the air water cylinder and tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927446 ↗MalfunctionSep 29, 2026Contamination
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that the c-cover, the connecting tube and the universal cord had foreign objects. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927437 ↗MalfunctionSep 28, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925996 ↗MalfunctionSep 23, 2026Failure to Clean Adequately
The customer reported that gold threads were visible at the distal end of an olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873639 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer reported Error code B30 (Scope communication error) involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863536 ↗MalfunctionSep 21, 2026No Display/Image; Communication or Transmission Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847981 ↗MalfunctionSep 21, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects in air water cylinder and tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845674 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
The customer reported scope error (E217) during reprocessing involving an Olympus colonovideoscope. There were no reports of involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837654 ↗MalfunctionSep 19, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832720 ↗MalfunctionSep 17, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812035 ↗MalfunctionSep 16, 2026Communication or Transmission Problem; Connection Problem; Failure to Clean Adequately
The customer reported the Communication error E216, E237 and E226 during a inspection for use. During the initial evaluation of the device it was observed, E217 (Scope error) occurred and Micro connector unit in Scope connector is dirty. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792735 ↗MalfunctionSep 15, 2026Image Display Error/Artifact
The customer reported the colonovideoscope had image disturbances during reprocessing. During the initial evaluation of the device it was observed that the image disappeared. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766928 ↗MalfunctionSep 10, 2026Erratic or Intermittent Display; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718460 ↗MalfunctionSep 10, 2026No Display/Image; Communication or Transmission Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718166 ↗MalfunctionSep 10, 2026Material Protrusion/Extrusion
The customer returned the colonovideoscope to the service center for a separate issue. During the initial evaluation of the device, braids protruding from the connecting tube were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703770 ↗MalfunctionSep 9, 2026Device Reprocessing Problem; Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701664 ↗MalfunctionSep 8, 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 foreign objects were found in the air water cylinder and in the air water tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672063 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for a separate issue. During device analysis, the service repair technician identified white foreign material within the auxiliary water tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671513 ↗MalfunctionSep 8, 2026Corroded; Failure to Clean Adequately
The customer returned the Colonovideoscope to the service center for a separate issue. During device analysis, the service technician identified corrosion on the auxiliary water inlet, foreign material on the C-cover, foreign material on the nozzle, and dirt on the light guide cover glass. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667507 ↗MalfunctionSep 8, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50659155 ↗MalfunctionSep 2, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569244 ↗MalfunctionSep 2, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568328 ↗
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-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-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, 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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