EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (UDI 04953170237287)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 is a flexible camera scope used to examine the colon. Most of the 35 reports describe cleaning and reprocessing problems — residue left inside the scope, contamination of the air/water channel, and debris found during service inspection — along with a few lighting and image failures found before patient use. There are no deaths and one injury. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170237287), received between Feb 6, 2019 and Aug 25, 2026 — classified as 1 injury, 33 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (14 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 Adequately14
- Microbial Contamination of Device6
- Device Reprocessing Problem5
- Break1
- Contamination1
- Device Contamination with Chemical or Other Material1
- Display or Visual Feedback Problem1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Known Impact Or Consequence To Patient3
- Blood Loss1
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Display or Visual Feedback Problem; Overheating of Device; Residue After Decontamination
The customer reported the burnt out light bulb during device inspection for use for Olympus colonovideoscope. During the initial evaluation of the device no illumination and foreign objects in light guide was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427157 ↗MalfunctionJul 20, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882294 ↗MalfunctionJul 20, 2026Failure to Power Up
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 WAS OBTAINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875784 ↗MalfunctionJul 15, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR CENTER IDENTIFIED FOREIGN OBJECT ON THE AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829426 ↗MalfunctionMar 4, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A WHITE FOREIGN MATERIAL AT THE AIR WATER CYLINDER AND THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512417 ↗MalfunctionFeb 10, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE AIR WATER CYLINDER AND CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301505 ↗MalfunctionJan 22, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A LACK OF IMAGE ON THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24141889 ↗MalfunctionJan 21, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE AIR/WATER TUBE AND THE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131672 ↗MalfunctionJan 20, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS AT AIR WATER CYLINDER AND TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24122895 ↗MalfunctionJan 7, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED AN IMAGE THAT TURNED ON AND OFF EVERY TWO SECONDS DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989465 ↗MalfunctionOct 28, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE SUBJECT DEVICE HAD FOREIGN OBJECT IN THE AIR WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404251 ↗MalfunctionAug 4, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 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 22704474 ↗MalfunctionJul 28, 2025Melted; Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BURN ON LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631564 ↗MalfunctionJul 23, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN OBJECTS IN THE AIR WATER CYLINDER AND TUBE, AND THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579151 ↗MalfunctionJul 21, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555270 ↗MalfunctionMar 25, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED AN AIR/WATER-CYLINDER (TUBE) HAD WHITE FOREIGN OBJECTS AND AN AIR/WATER -TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690007 ↗MalfunctionAug 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COLONOVIDEOSCOPE EXHIBITED THE NOZZLE, THE ADHESIVE ON THE BENDING SECTION COVER AND THE BENDING SECTION COVER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20021689 ↗MalfunctionJun 19, 2024Microbial Contamination of Device; Microbial 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 19566843 ↗MalfunctionMay 20, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED THE JET-TUBE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19352013 ↗MalfunctionApr 26, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON AIR/WATER CYLINDER, AIR/WATER TUBE AND JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19188824 ↗MalfunctionApr 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN THE AIR WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19068248 ↗MalfunctionDec 12, 2023Failure to Clean Adequately; Failure to Clean Adequately
IT WAS ADDED THAT THE CUSTOMER-REPORTED EVENT OCCURRED AT THE END OF AN UNSPECIFIED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18313670 ↗MalfunctionNov 30, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE EVIS EXERA II COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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 18237887 ↗MalfunctionOct 17, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II COLONOVIDEOSCOPE, HAD LOOSE TIE RODS. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE EVALUATION FOUND THAT THE JET TUBE HAD A FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17950905 ↗MalfunctionJan 9, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II COLONOVIDEOSCOPE AIR AND WATER CHANNEL WAS OBSTRUCTED. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16124393 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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