EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL (UDI 04953170339615)Recalls & reported problems
Olympus Medical Systems Corp. · CF-H180AL EVIS EXERA II HD 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 colonoscope is a flexible scope used to examine the colon. Of its 317 reports, 298 are malfunctions and 19 are injuries, mostly describing poor cleaning and missing or poor images, while some mention bowel perforation. The 1 recall, begun in April 2022 and now closed, covers a camera unit that may not fit this scope. Reports rose to 219 in the last 12 months from 34 in the previous 12.
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
- 323
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 04953170339615), received between Oct 10, 2017 and Sep 25, 2026 — classified as 19 injuries, 304 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (98 reports).
1 FDA recall record name this device's identifier.
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
- Apr 22, 2022Class IITerminated
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Z-1274-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately98
- No Display/Image57
- Poor Quality Image48
- Erratic or Intermittent Display26
- Device Reprocessing Problem19
- Residue After Decontamination10
- Display or Visual Feedback Problem8
- Pressure Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions294
- Bowel Perforation14
- Hemorrhage/Blood Loss/Bleeding4
- Perforation4
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that water supply and white air water channel has white residue. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899844 ↗MalfunctionSep 25, 2026Poor Quality Image
The customer reported the colonovideoscope had static monitor connection during inspection for use. During the initial evaluation of the device, static and noise in the image were observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892965 ↗MalfunctionSep 23, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875856 ↗MalfunctionSep 22, 2026No Display/Image
The customer reported that no image was displayed during inspection for use involving an olympus colonovideoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853788 ↗MalfunctionSep 21, 2026Corroded
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, corrosion was observed on the air/water inlet. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842352 ↗MalfunctionSep 19, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833553 ↗MalfunctionSep 9, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the device, foreign material in the nozzle was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688601 ↗MalfunctionSep 2, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571279 ↗MalfunctionAug 31, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532298 ↗MalfunctionAug 31, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520001 ↗MalfunctionAug 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509838 ↗MalfunctionAug 14, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for evaluation related to a separate issue. During device evaluation, the repair center identified residue in light guide (LG) lens . There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248682 ↗MalfunctionAug 4, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133395 ↗MalfunctionJul 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059697 ↗MalfunctionJul 27, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50044339 ↗MalfunctionJul 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25896737 ↗MalfunctionJul 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891739 ↗MalfunctionJul 20, 2026Erratic or Intermittent Display
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING DEVICE EVALUATION, THE REPAIR CENTER IDENTIFIED A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25876018 ↗MalfunctionJul 17, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED DISTORTED IMAGE DURING AN INSPECTION FOR USE INVOLVING A COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861135 ↗MalfunctionJul 15, 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 CLOGGED NOZZLE WITH FOREIGN DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25826059 ↗MalfunctionJul 14, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR AN UNRELATED ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN FOUND THAT THE OBJECTIVE LENS WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25811843 ↗MalfunctionJul 7, 2026Thermal Decomposition of Device
THE CUSTOMER REPORTED SCOPE WAS BURNED ON THE END DURING A COLONOSCOPY DIAGNOSTIC PROCEDURE INVOLVING A COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733477 ↗MalfunctionJun 27, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED AN INTERNAL SHREDDING DAMAGE IN BIOPSY CHANNEL DURING REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646361 ↗MalfunctionJun 24, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN IDENTIFIED DEBRIS INSIDE THE FORCEPS PASSAGE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612801 ↗MalfunctionJun 24, 2026Output Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT ERROR CODE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610014 ↗
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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