EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DIRecalls & 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
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 has 166 reports, with no deaths and no injuries. Many reports describe scopes that were not cleaned adequately, microbial contamination, and foreign material found inside the air and water channels. The device has 1 recall, still open, from September 2023, over channels that may stay wet after drying, which could carry a risk of infection. Reports rose from 30 in the prior 12 months to 52 in the latest 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
- 164
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 04953170363696), received between Nov 20, 2018 and Sep 30, 2026 — classified as 164 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (92 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately92
- Device Reprocessing Problem23
- Microbial Contamination of Device23
- Communication or Transmission Problem10
- No Display/Image6
- Poor Quality Image6
- Contamination3
- Erratic or Intermittent Display3
Patient problems
- No Clinical Signs, Symptoms or Conditions155
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Clean Adequately
During the initial evaluation of the colonovideoscope, it was found that white foreign material was present within the air/water tube and air/water cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943255 ↗MalfunctionAug 29, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510271 ↗MalfunctionAug 28, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499959 ↗MalfunctionAug 7, 2026Device Reprocessing Problem
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device, white foreign material on air water cylinder and air water tube was observed. The repair center technician indicated that the most likely cause of the white foreign material on air water cylinder and air water tube was not established. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184043 ↗MalfunctionJul 30, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093855 ↗MalfunctionJul 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063561 ↗MalfunctionJul 27, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50018776 ↗MalfunctionJul 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 FOREIGN OBJECTS IN AIR/WATER CHANNEL AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749611 ↗MalfunctionJul 6, 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 FOREIGN OBJECTS IN AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25722812 ↗MalfunctionJun 30, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD WHITE FOREIGN OBJECTS IN THE AIR WATER CYLINDER AND AIR WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668339 ↗MalfunctionJun 25, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT AIR WATER CYLINDER, TUBE AND CONNECTING TUBE HAD FOREIGN OBJECTS WAS FOUND. IT WAS DETERMINED THAT THE AIR WATER CYLINDER, TUBE AND CONNECTING TUBE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626742 ↗MalfunctionJun 6, 2026Poor Quality Image
THE CUSTOMER REPORTED THAT THE IMAGE DISPLAYED 6 STRIPES AT THE BOTTOM RIGHT PANEL ON AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25419522 ↗MalfunctionJun 3, 2026Microbial Contamination of Device
IT WAS REPORTED THE COLONOVIDEOSCOPE TESTED POSITIVE FOR CONTAMINATION DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382567 ↗MalfunctionJun 2, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE JET TUBE, AIR/WATER (A/W) CYLINDER, A/W TUBE, AND CONNECTING TUBE HAD FOREIGN OBJECTS HAD FOREIGN OBJECTS, AS WELL AS THE FORCEPS CHANNEL PORT HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368241 ↗MalfunctionMay 29, 2026No Display/Image; Communication or Transmission Problem
THE CUSTOMER REPORTED THE SCREEN FROM THE COLONOVIDEOSCOPE SUDDENLY WENT BLACK AND A SCOPE COMMUNICATION ERROR CODE B30 APPEARED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336244 ↗MalfunctionMay 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIALS AT AIR-WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323540 ↗MalfunctionMay 14, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD BLUE VERTICAL STRIPES ON THE SCREEN. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174435 ↗MalfunctionMay 4, 2026Communication or Transmission Problem; Failure to Clean Adequately
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED SCOPE COMMUNICATION ERROR CODE E216. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065899 ↗MalfunctionApr 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 25047232 ↗MalfunctionApr 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013610 ↗MalfunctionApr 20, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIALS ON THE AIR/WATER CHANNEL OF THE DISTAL END INSERTION PART AND THE AIR/WATER TUBES OF THE UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925387 ↗MalfunctionApr 17, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD AN INSTRUMENT INFILTRATED WITH FOREIGN MATERIAL AND A BLURRY IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915901 ↗MalfunctionApr 16, 2026No Display/Image; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED E216 SCOPE COMMUNICATION ERROR AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893673 ↗MalfunctionApr 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN THE AIR¿WATER TUBE, THE AIR¿WATER CYLINDER, AND THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858425 ↗MalfunctionApr 9, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE C-COVER AND LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837883 ↗
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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