EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190I (REF N3802441)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA lll COLONOVIDEOSCOPE (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Exera CF-H190I colonoscope is a flexible camera scope used to examine the colon. The 66 reports mostly describe cleaning and reprocessing problems — leftover white or black material inside the scope's air/water tube, nozzle and tip, and bacterial growth found in its channels after reprocessing. No deaths and no injuries were reported, and 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
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04953170436635), received between May 5, 2023 and Jan 24, 2025 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (40 reports).
8 other recalls cover devices cleared under the same FDA submission (K131780); they may or may not involve this specific model.
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 Adequately40
- Microbial Contamination of Device24
- Device Reprocessing Problem4
- Thermal Decomposition of Device2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE AIR/WATER CYLINDER AND TUBE HAD FOREIGN OBJECTS (WHITE FOREIGN MATERIALS), AND THE PLASTIC DISTAL COVER AND BENDING SECTION COVER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21230360 ↗MalfunctionNov 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A CLOGGED NOZZLE WITH A BLACK RUBBERY FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20640201 ↗MalfunctionNov 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL EXITING THE AIR/WATER NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20638224 ↗MalfunctionNov 5, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THE COLONOVIDEOSCOPE WAS USED IN CLOSE PROXIMITY TO A HIGH ENERGY ENDOTHERAPY ACCESSORY. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611190 ↗MalfunctionOct 30, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONO VIDEOSCOPE TESTED POSITIVE FOR TOTAL AEROBIC FLORA (BACILLUS SP.) 2 COLONY FORMING UNITS (CFU)/100ML IN THE ASPIRATION CHANNEL, TOTAL AEROBIC FLORA (PSEUDOMONAS AERUGINOSA) 200 COLONY CFU/100ML IN THE INSUFFLATION CHANNEL AND TOTAL AEROBIC FLORA (PSEUDOMONAS AERUGINOSA) 13 COLON CFU/100ML IN THE OPERATOR CHANNEL. 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 20568592 ↗MalfunctionOct 29, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE EXERA COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20558567 ↗MalfunctionOct 28, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THERE WERE FOREIGN OBJECTS IN THE JET TUBE OF THE COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543910 ↗MalfunctionOct 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE C-COVER (PLASTIC DISTAL END COVER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537738 ↗MalfunctionOct 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
DURING THE INSPECTION AND TESTING OF THE COLONOVIDEOSCOPE FOREIGN MATERIAL CLOGGED NOZZLE, AND WAS ALSO OBSERVED IN AIR/WATER (A/W) CYLINDER AND TUBE, J-TUBE, CONNECTING TUBE, ADHESIVE ON THE DISTAL SHEATH. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20525308 ↗MalfunctionOct 22, 2024Microbial Contamination of Device; Failure to Clean Adequately; Microbial Contamination of Device; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON 4 PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20511246 ↗MalfunctionOct 22, 2024Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON 4 PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20510692 ↗MalfunctionOct 22, 2024Microbial Contamination of Device; Failure to Clean Adequately; Microbial Contamination of Device; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON 4 PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20505944 ↗MalfunctionOct 21, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 100 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX, 5 CFU¿S OF KLEBSIELLA PNEUMONIAE AND 5 CFU¿S OF ESCHERICHIA COLI. A SUBSEQUENT TEST WAS PERFORMED, AND THE SCOPE TESTED POSITIVE FOR 100 CFUS OF KLEBSIELLA PNEUMONIAE AND 1 CFU OF PSEUDOMONAS AERUGINOSA. ALL CHANNELS WERE SAMPLED. 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 20495540 ↗MalfunctionOct 18, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20487834 ↗MalfunctionOct 11, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR >1000 COLONY FORMING UNITS (CFUS) OF CITROBACTER KOSERI (C.DIVERSUS) AND >1000 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER KOBEI ON SEPTEMBER 25TH, 2024. ALL CHANNELS WERE SAMPLED. 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 20427448 ↗MalfunctionOct 8, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE INITIALLY TESTED POSITIVE FOR MORE THAN 100 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA IN BOTH THE AIR/WATER CHANNEL AND SUCTION CHANNEL. EIGHT DAYS LATER, THE SCOPE WAS RESAMPLED AND TESTED POSITIVE FOR 6 CFUS OF PSEUDOMONAS AERUGINOSA IN THE AIR/WATER CHANNEL AND 20 CFUS OF PSEUDOMONAS AERUGINOSA IN THE SUCTION CHANNEL. 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 20403831 ↗MalfunctionOct 1, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A BURN ON THE PROBE COVER, DIRT ON THE OBJECTIVE LENS, FOREIGN OBJECTS ON THE PROBE COVER, AND FOREIGN OBJECTS ON THE ADHESIVE OF THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343628 ↗MalfunctionSep 3, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA III COLONOVIDEOSCOPE EXHIBITED INCORRECT REPROCESSING AND FOREIGN MATERIAL IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126556 ↗MalfunctionAug 27, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE NOZZLE AND THE INSUFFLATION CHANNEL OF THE COLONO VIDEOSCOPE ARE CLOGGED BY A DARK RUBBERY MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20074767 ↗MalfunctionAug 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE NOZZLE OF THE INSUFFLATION CHANNEL OF THE COLONOVIDEOSCOPE WAS CLOGGED BY A CHEMICAL RESIDUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20057185 ↗MalfunctionAug 21, 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 20010509 ↗MalfunctionJul 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COLONOVIDEOSCOPE EXHIBITED A NOZZLE THAT WAS CLOGGED BY A BLACK RUBBERY MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19750371 ↗MalfunctionJul 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704018 ↗MalfunctionJul 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698004 ↗MalfunctionJun 11, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNIT (CFUS) OF BACILLACEAE. ALL CHANNELS WERE SAMPLED. 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 19515310 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.
- Z-1210-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0341-2024 · Sep 25, 2023 · Open, ClassifiedColonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
- Z-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil
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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