EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (UDI 04953170339905)Recalls & reported problems
Olympus Medical Systems Corp. · "PCF-H180AL EVIS EXERA II COLONOSCOPE" · Class 2
All models of EVIS EXERA II COLONOVIDEOSCOPE (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II is a flexible colonoscope. Its 251 reports often describe incomplete cleaning and disinfecting, no display or image, and poor image quality, and many were sent to a service center with no patient involved. The reports include 8 injuries and no deaths. Reports rose from 22 in the previous 12 months to 174 in the most recent 12 months. No recalls name this device.
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
- 251
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 04953170339905), received between Nov 27, 2019 and Jul 27, 2026 — classified as 8 injuries, 243 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (67 reports).
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
Most reported problems
Device problems
- Failure to Clean Adequately67
- No Display/Image55
- Poor Quality Image30
- Erratic or Intermittent Display28
- Device Reprocessing Problem21
- Residue After Decontamination11
- Contamination6
- Display or Visual Feedback Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions238
- Hemorrhage/Blood Loss/Bleeding4
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
- Perforation2
- Laceration(s)1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 251 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003016 ↗MalfunctionJul 20, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE EVALUATION, IMAGE NOISE WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882640 ↗MalfunctionJul 13, 2026No Display/Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE REPAIR CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR CENTER IDENTIFIED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25799724 ↗MalfunctionJun 24, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED GLITCHING ON MONITOR FOR AN OLYMPUS COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612426 ↗MalfunctionJun 17, 2026Erratic or Intermittent Display
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE, THE SERVICE REPAIR TECHNICIAN INDICATED FLICKERING AND NOISY IMAGE WHEN ANGULATING THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540379 ↗MalfunctionJun 12, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD WHITE STAIN IN AIR -WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490592 ↗MalfunctionJun 10, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE REPAIR TECHNICIAN OBSERVED BURN DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463302 ↗MalfunctionJun 10, 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 INDICATES THAT NOZZLE CLOGGED WITH FIBROUS FOREIGN MATERIAL WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461614 ↗MalfunctionJun 10, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED SCREEN GLITCHES DURING REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460898 ↗MalfunctionJun 10, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD BURN MARKS ON DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459672 ↗MalfunctionJun 10, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT UNKNOWN FIBRUOUS MATERIAL IN NOZZLE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459496 ↗MalfunctionJun 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, WHITE FOREIGN MATERIALS IN AIR WATER CHANNEL AND CYLINDER WAS OBSERVED. THE REPAIR CENTER TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE CAUSE OF WHITE FOREIGN MATERIAL COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25427296 ↗MalfunctionJun 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 MATERIAL INSIDE AIR/WATER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25426564 ↗MalfunctionJun 4, 2026No Display/Image; Image Display Error/Artifact
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT THE IMAGE WAS NOISY AND THERE WAS NO IMAGE, LIKELY DUE TO AN ELECTRICAL COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25392933 ↗MalfunctionJun 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD WHITE FOREIGN MATERIAL IN AIR WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352837 ↗MalfunctionJun 1, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED MISSING IMAGE AND FLICKERING AFTER AERATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351818 ↗MalfunctionJun 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE DEVICE EXHIBITED RESIDUE AT AIR/WATER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350516 ↗MalfunctionMay 29, 2026Erratic or Intermittent Display
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, IT WAS OBSERVED THAT THE IMAGE INTERMITTENTLY FLICKERED WHEN ANGULATING THE KNOBS OR MOVING THE BENDING SECTION, DUE TO AN ELECTRICAL PROBLEM. IT WAS DETERMINED THAT THE ELECTRICAL COMPONENT REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336886 ↗MalfunctionMay 29, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OBJECTIVE LENS WAS FOUND TO BE DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334695 ↗MalfunctionMay 29, 2026Melted; Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE, WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BURNT C-COVER AND WHITE RESIDUE IN CHANNEL WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE BURNT C-COVER WAS DUE TO COMPONENT FAILURE AND FOR WHITE RESIDUE CAUSE COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331895 ↗MalfunctionMay 28, 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 INDICATES THAT THE AIR/WATER NOZZLE HAD ADVANCE DIAGNOSTICS RESIDUE. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321860 ↗MalfunctionMay 28, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, PLASTIC FOREIGN MATERIAL WAS FOUND STUCK INSIDE THE FORCEPS PASSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320998 ↗MalfunctionMay 27, 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 A PLASTIC FOREIGN MATERIAL IN NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304197 ↗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 MEDICAL DEVICE REPORTABLE EVENT. HOWEVER, MEDICAL DEVICE REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FOREIGN MATERIAL IN NOZZLE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256820 ↗MalfunctionMay 20, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE PRESENTED BURN MARK ON THE DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25227340 ↗
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
- 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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