EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TLRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III COLONOVIDEOSCOPE (6)
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 camera scope used to look inside the colon. Many of the 178 reports describe scopes that did not clean properly or had residue inside. The reports include 174 malfunctions, 4 injuries and no deaths. Reports from the last 12 months number 72, up from 15 in the 12 months before. Two recalls are open, covering repaired scopes missing protective adhesive and water left in scope channels.
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
- 184
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 04953170420702), received between Oct 19, 2021 and Sep 30, 2026 — classified as 4 injuries, 180 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (98 reports).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K192793); 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-1212-2024 · 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately98
- Communication or Transmission Problem21
- Microbial Contamination of Device20
- No Display/Image15
- Device Reprocessing Problem12
- Residue After Decontamination8
- Poor Quality Image5
- Contamination4
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- Inflammation2
Recent adverse event reports
The 25 most recent of 184 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image; Communication or Transmission Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954835 ↗MalfunctionSep 29, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939151 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937750 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, dark residue was observed in the small light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913005 ↗MalfunctionSep 23, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875827 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, cylinder and channel with white residue were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859588 ↗MalfunctionSep 9, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692703 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display; No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50561423 ↗MalfunctionAug 20, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351401 ↗MalfunctionAug 18, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50295734 ↗MalfunctionAug 17, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277819 ↗MalfunctionAug 14, 2026Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254694 ↗MalfunctionAug 10, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device it was observed, white residue in air water channel and air water cylinder were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194135 ↗MalfunctionJul 30, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082528 ↗MalfunctionJul 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068321 ↗MalfunctionJun 26, 2026Residue After Decontamination
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 WHITE RESIDUE IN AIR WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638215 ↗MalfunctionJun 26, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT DEVICE HAD WHITE RESIDUE IN THE AIR WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635891 ↗MalfunctionJun 24, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE REPAIR TECHNICIAN FOUND WHITE RESIDUE INSIDE THE CYLINDER AND CHANNEL ALSO DEBRIS IN THE LENS, CAUSE NOT IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25607179 ↗MalfunctionJun 19, 2026Failure to Clean Adequately
THE CUSTOMER REPORTED THAT DEBRIS HAD BEEN NOTICED ON THE CLEANING BRUSHES DURING REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25568430 ↗MalfunctionJun 5, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE DURING A REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414713 ↗MalfunctionJun 4, 2026Flare or Flash; Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED BURN MARKS ON THE DISTAL END PLASTIC COVER AND WHITE RESIDUE INSIDE THE AIR/WATER SUPPLY CHANNEL AND AUXILIARY WATER FLOW CHANNEL AND ALSO IN THE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25394589 ↗MalfunctionMay 26, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE WAS RETURNED TO OLYMPUS FOR ASSET RETURN HOWEVER AN MDR REPORTABLE FAILURE WAS FOUND DURING INSPECTION OF THE DEVICE, THE AIR/WATER CYLINDER HAD WHITE FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279577 ↗MalfunctionMay 22, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF NO CUSTOMER ALLEGATION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, WHITE RESIDUE IN THE AIR WATER CHANNEL AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25261912 ↗MalfunctionMay 19, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD HIGH GLUE IN C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25218776 ↗MalfunctionMay 14, 2026No Display/Image
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD NO IMAGE. THE ISSUE WAS FOUND DURING THE MIDDLE OF AN ENDOSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172375 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192793. One submission often covers many models, so check the product and lot details in each record.
- Z-1213-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-HQ190L.
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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