EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL (UDI 04953170202339)Recalls & reported problems
Olympus Medical Systems Corp. · 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 has 247 reports on file, with 2 deaths and 16 injuries. Many describe the scope failing to clean adequately, contamination, or reprocessing problems, and others describe poor images or blank screens. A few patients mention bleeding, perforation or viral infection. No recalls name this device, and reports rose to 64 in the latest year from 24 in the year before.
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
- 252
- Deaths reported
- 2
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 04953170202339), received between May 30, 2018 and Sep 30, 2026 — classified as 2 deaths, 16 injuries, 234 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (107 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 Adequately107
- Microbial Contamination of Device37
- Device Reprocessing Problem34
- Poor Quality Image15
- No Display/Image13
- Adverse Event Without Identified Device or Use Problem9
- Corroded7
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions215
- No Known Impact Or Consequence To Patient12
- Hemorrhage/Blood Loss/Bleeding4
- No Consequences Or Impact To Patient4
- Perforation4
- Viral Infection4
- Death2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951833 ↗MalfunctionSep 17, 2026Erratic or Intermittent Display
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, noise and intermittent image were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805519 ↗MalfunctionSep 10, 2026Poor Quality Image
The customer returned the colonovideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the device noise image occurs. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715484 ↗MalfunctionSep 10, 2026Device Reprocessing Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that c-cover and adhesive on distal sheath had foreign objects. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50705283 ↗MalfunctionSep 9, 2026Device Reprocessing Problem
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that foreign objects were present on the auxiliary jet channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684115 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572332 ↗MalfunctionAug 13, 2026No Display/Image; Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244223 ↗MalfunctionAug 5, 2026Device Reprocessing Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143340 ↗MalfunctionJul 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055664 ↗MalfunctionJul 3, 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 TECHNICIAN IDENTIFIED THE DEVICE HAD FOREIGN MATERIALS IN AUXILIARY WATER CHANNEL (J-TUBE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703446 ↗MalfunctionJul 1, 2026No Device Output
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT NO ILLUMINATION OBTAINED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683036 ↗MalfunctionJun 26, 2026Poor Quality Image
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT NOISY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641118 ↗MalfunctionJun 11, 2026Poor Quality Image
THE CUSTOMER REPORTED LIMITED FIELD OF VIEW ON THE RIGHT SIDE, AND A LONGITUDINAL SMEAR ON THE MONITOR DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473085 ↗MalfunctionJun 6, 2026No Display/Image
THE CUSTOMER REPORTED THE SCREEN GOES BLANK DURING UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418800 ↗MalfunctionJun 4, 2026Display or Visual Feedback Problem; Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD DIRT ON THE OBJECTIVE LENS AND THE IMAGE DID NOT APPEAR COMPLETELY ON THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395071 ↗MalfunctionJun 4, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, FOREIGN OBJECTS IN NOZZLE WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FOREIGN OBJECTS IN NOZZLE COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25392041 ↗MalfunctionMay 31, 2026Corroded
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, CORRODED NOZZLE WAS FOUND. IT WAS DETERMINED THAT THE NOZZLE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342465 ↗MalfunctionMay 22, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION ON THE ELECTRICAL CONNECTOR AND THE SCOPE COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25254370 ↗MalfunctionMay 19, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219843 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECT IN AUXILIARY TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153732 ↗MalfunctionMay 8, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE LIGHT GUIDE ROD LENS AT THE DISTAL END OF THE INSERTION PART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127127 ↗MalfunctionMay 1, 2026Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD A LINE VISIBLE IN THE PICTURE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057008 ↗MalfunctionApr 21, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD NO IMAGE. THE EVENT HAD OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM. NO IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945820 ↗MalfunctionApr 21, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE PRESENTED FOREIGN OBJECTS IN THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943254 ↗MalfunctionApr 16, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A STICKY AT THE SCOPE CONNECTOR COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900956 ↗
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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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