EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190IRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III COLONOVIDEOSCOPE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus Exera III colonoideoscope is a flexible camera used to examine the colon. The 34 reports mostly describe residue, blockages and bacterial contamination found inside the air, water and jet channels during cleaning and inspection, with 32 malfunctions, 2 injuries and no deaths. One open recall, started in September 2023, concerns scopes returned after repair with a wet channel, which the firm says can allow contamination and infection.
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
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170416132), received between Nov 3, 2021 and Nov 26, 2024 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (19 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K192793); 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
Recalls naming this device
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately19
- Microbial Contamination of Device13
- Adverse Event Without Identified Device or Use Problem2
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE DEVICE WAS RE-TESTED AND TESTED NEGATIVE ON THE SECOND TEST HOWEVER INFECTION CONTROL WITHIN THE HOSPITAL NOTED IT WAS AN UNUSUAL CULTURE. 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 20784386 ↗MalfunctionNov 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A CLOGGED JET CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621100 ↗MalfunctionNov 4, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL REMAINING IN THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20598848 ↗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'S PLASTIC DISTAL END COVER WAS BURNED AND FOREIGN FATERIAL WAS FOUND IN THE JET CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344192 ↗MalfunctionSep 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE 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 20189083 ↗MalfunctionSep 6, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNSPECIFIED NUMBER OF COLONY FORMING UNITS (CFUS) OF ENTEROCOCCUS FAECALIS AND ENTEROCOCCUS FAECIUM. THE SCOPE WAS RESAMPLED THREE DAYS LATER AND WAS POSITIVE FOR AN UNSPECIFIED NUMBER OF CFUS OF ESCHERICHIA COLI AND OTHER UNSPECIFIED MICROORGANISMS. 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 20157837 ↗MalfunctionSep 3, 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 CYLINDER, THE AIR WATER TUBE, THE JET TUBE, AND THE CONTROL SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127010 ↗MalfunctionAug 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919174 ↗MalfunctionJul 11, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. IT WAS NOTED THAT THE DEVICE WAS CONTAMINATED EVEN AFTER TWO ROUNDS OF DISINFECTION. THE ISSUE WAS FOUND DURING REPROCESSING. 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 19719412 ↗MalfunctionJun 27, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED THE AIR/WATER, AIR WATER TUBE AND JET TUBE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629506 ↗MalfunctionMay 17, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS CULTURED THREE TIMES AND TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE/PREP FOR USE. 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 19340209 ↗MalfunctionApr 3, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE OF THE AIR/WATER CYLINDER, TUBE, AND THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19037540 ↗MalfunctionFeb 26, 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 RECEIPT INSPECTION. 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 18781053 ↗MalfunctionFeb 26, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 66 COLONY FORMING UNITS (CFUS) OF KLEBSIELLA PNEUMONIAE. 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 18778967 ↗MalfunctionFeb 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A WHITE FOREIGN MATERIAL INSIDE 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 18720971 ↗MalfunctionFeb 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN A CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18638850 ↗MalfunctionFeb 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL ON THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18638586 ↗MalfunctionFeb 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE AIR/WATER (AW) TUBE, AW CYLINDER, AND THE JET TUBE (J-TUBE) HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629721 ↗MalfunctionFeb 1, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE AIR/WATER CYLINDER AND AIR/WATER TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627084 ↗MalfunctionDec 18, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE FLEX VIDEO SCOPE BLUE RING PROTECTOR HAD A LOOSE HANDLE. THE ISSUE WAS FOUND DURING AN UNKNOWN EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL IN THE JET TUBE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18345880 ↗MalfunctionDec 11, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III 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 18301791 ↗MalfunctionDec 1, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE IS FRAGILE, THE BONDS BEGIN TO BREAK. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE JET TUBE WAS FOUND TO HAVE WHITE FOREIGN MATERIAL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18245257 ↗MalfunctionNov 30, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE MICROBIOLOGICAL CONTAMINATION 4 TIMES. ON 27OCT2023 (LOCAL TIME), TESTING DETECTED 100 COLONY FORMING UNITS (CFUS)/CHANNEL OF ESCHERICHIA COLI AND ON 30OCT2023 AFTER RETREATMENT, TESTING DETECTED 3 CFU/CHANNEL OF ESCHERICHIA COLI. ON 31OCT2023, AFTER REPROCESSING WITH ENZIQURE DETERGENT, THE DEVICE TESTED POSITIVE FOR 6 CFU/CHANNEL OF PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA. ON 03NOV2023, AFTER ADDITIONAL REPROCESSING WITH ENZIQURE DETERGENT, THE DEVICE TESTED POSITIVE FOR 6 CFU/CHANNEL 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 18238245 ↗MalfunctionAug 8, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III COLONOVIDEOSCOPE WORKING CHANNEL WAS CLOGGED. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: A FOREIGN MATERIAL IN THE CHANNEL TUBE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17482405 ↗MalfunctionJul 2, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE POSITIVE TEST OCCURRED DURING VALIDATION FOR AN ENDOSCOPE REPROCESSOR. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17244417 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192793. One submission often covers many models, so check the product and lot details in each record.
- Z-1212-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190TL.
- Z-1213-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-HQ190L.
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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