EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (UDI 04953170202544)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 colonoscope is a flexible video scope used to look inside the colon. Most of the 47 reports describe cleaning and reprocessing trouble — residue left inside the scope or clogging in the air/water channel — plus corrosion, a few cases of possible microbial contamination, and pixelated or missing images on the monitor. Three reports involve injuries and none describe a death. 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
- 47
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04953170202544), received between Apr 25, 2019 and Jul 21, 2026 — classified as 3 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (24 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 Adequately24
- Device Reprocessing Problem9
- Microbial Contamination of Device3
- Adverse Event Without Identified Device or Use Problem2
- Corroded2
- Poor Quality Image2
- Break1
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Known Impact Or Consequence To Patient3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Poor Quality Image
THE CUSTOMER REPORTED THAT THE SCREEN HAD POOR VISIBILITY AND WAS PIXELATED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25894308 ↗MalfunctionMay 10, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE AIR WATER TUBE AND CYLINDER WITH FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133697 ↗MalfunctionOct 15, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288845 ↗MalfunctionAug 27, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIALS IN AIR/ WATER CHANNEL AND AIR/ WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909814 ↗MalfunctionAug 8, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD EXHIBITED AW-TUBE (AIR/WATE) AND AW-CYLINDER(AIR/WATER) HAVE FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750577 ↗MalfunctionJul 25, 2025Corroded; Poor Quality Image; Dull, Blunt; Corroded; Poor Quality Image; Dull, Blunt
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610771 ↗MalfunctionJul 23, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A JAMMED CLIP. THE ISSUE WAS FOUND DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22578083 ↗MalfunctionJul 23, 2025Device Reprocessing Problem; Corroded; Crack; Degraded; Electrical /Electronic Property Problem; Gas/Air Leak; No Apparent Adverse Event; Device Reprocessing Problem; Corroded; Crack; Degraded; Electrical /Electronic Property Problem; Gas/Air Leak; No Apparent Adverse Event
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED AIR/WATER-CYLINDER (TUBE) HAD FOREIGN OBJECTS AND THE SHEET HOLDER UNIT HAD CORROSION DUE TO WATER LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576308 ↗MalfunctionMay 13, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014011 ↗MalfunctionApr 30, 2025Melted; Melted
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAS A BURN ON THE CAMERA COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21933153 ↗MalfunctionMar 14, 2025Material Deformation; Material Deformation
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A DEFORMED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21610064 ↗MalfunctionNov 11, 2024Microbial Contamination of Device; Failure to Clean Adequately; Microbial Contamination of Device; Failure to Clean Adequately
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "A NEW DRYING METHOD OF THERMOLABILE FLEXIBLE ENDOSCOPE CHANNELS BY LAMINAR AND TURBULENT AIRFLOW ¿ A PROSPECTIVE, RANDOMIZED-CONTROLLED, SINGLE-CENTER, PROOF-OF-CONCEPT TRIAL." LITERATURE SUMMARY: ABSTRACT BACKGROUND AND AIMS: INTERNATIONAL GUIDELINES SUGGEST DIFFERENT POSSIBILITIES FOR DRYING OF ENDOSCOPES DURING REPROCESSING. CLINICAL RESULTS OF THESE AVAILABLE DRYING METHODS ARE NOT SATISFACTORY. THE AIM OF THIS STUDY WAS TO COMPARE THE DRYING CYCLE OF A STANDARD ENDOSCOPE WASHER-DISINFECTOR (EWD) (STANDARD DRYING METHOD [SD]) WITH A SHORTENED MANDATORY DRYING BY THE EWD FOLLOWED BY A SPECIAL DRYING DEVICE USING LAMINAR AND TURBULENT AIR FLOW (NOVEL DRYING METHOD [ND]). MATERIALS AND METHODS: SIXTY ENDOSCOPES (DUODENOSCOPES, COLONOSCOCOPES AND GASTROSCOPES) FROM THREE DIFFERENT MANUFACTURERS UNDERWENT HIGH-LEVEL DISINFECTION AND DRYING DEPENDING ON THE RANDOMIZATION GROUP. OPERATIONAL TIME OF DRYING WAS MEASURED FOR BOTH GROUPS. RESIDUAL FLUID IN THE CHANNELS WAS MEASURED USING A LABORATORY SCALE. AFTER A 14 DAY STORAGE PERIOD, A SAMPLE OF THE ENDOSCOPE CHANNELS WAS OBTAINED TO DETERMINE BACTERIAL CONTAMINATION. RESULTS: ND HAD S
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20654762 ↗MalfunctionSep 10, 2024Failure to Clean Adequately; Failure to Clean Adequately
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 20182881 ↗MalfunctionAug 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE CONNECTING TUBE, AIR/WATER-CYLINDER, AIR/WATER-TUBE AND BENDING SECTION COVER OR DISTAL SHEATH HAVE FOREIGN MATERIAL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR USER INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20056337 ↗MalfunctionJun 20, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE JET TUBE HAD WHITISH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19573878 ↗MalfunctionApr 15, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19112398 ↗MalfunctionApr 1, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE HAD A WHITISH FOREIGN MATERIAL FOUND INSIDE OF THE AIR/WATER TUBE, AIR/WATER CYLINDER, AND JET-TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19013101 ↗MalfunctionMar 28, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED THE NOZZLE HAD FOREIGN OBJECTS ADDITIONAL THE ADHESIVE AROUND THE OBJECTIVE LENS, THE LIGHT GUIDE LENS, THE PLASTIC DISTAL END COVER, THE CONTROL KNOB, THE BENDING SECTION COVER AND THE CONNECTING TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18991825 ↗MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE COLONOVIDEOSCOPE, MISTAKENLY WAS USING A HIGH-LEVEL DISINFECTANT (MCKESSON OPA) AS THE 1ST STEP OF REPROCESSING INSTEAD OF ENZYMATIC DETERGENT (FLEXCLEAN). IT WAS DISCOVERED AND CORRECTED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913054 ↗MalfunctionMar 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18838752 ↗MalfunctionFeb 28, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE NOZZLE BEING CLOGGED-REMOVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797972 ↗MalfunctionFeb 20, 2024Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately
IT WAS REPORTED, THE COLONOVIDEOSCOPE DID NOT HAVE SUCTION AVAILABLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744129 ↗MalfunctionFeb 20, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE COLONOVIDEOSCOPE HAD FOREIGN MATERIAL EXITING FROM THE AIR/WATER NOZZLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738279 ↗MalfunctionFeb 19, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II COLONOVIDEOSCOPE EXHIBITED THE LIGHT GUIDE LENS HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730495 ↗MalfunctionFeb 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL WAS CLOGGED IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630088 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page