EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TIRecalls & 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 colonoscope is named in 77 adverse event reports describing mostly cleaning and reprocessing problems, including microbial contamination and foreign residue, with no deaths and 2 injuries. It has one open recall, started September 2023, about an unvalidated channel air-drying process that may leave water in the channel and risk 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
- 77
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170420719), received between Nov 30, 2021 and Jun 25, 2026 — classified as 2 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (46 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 Adequately46
- Microbial Contamination of Device25
- Contamination3
- Device Reprocessing Problem2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
- Pain1
- Rupture1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, FOREIGN OBJECT IN INSTRUMENT CHANNEL. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626659 ↗MalfunctionDec 22, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE EXHIBITED WHITE RESIDUE WITHIN THE AIR/WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871500 ↗MalfunctionSep 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052108 ↗MalfunctionNov 23, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ANGULATION CABLE ISSUE. THE ISSUE WAS FOUND DURING DIAGNOSTIC COLONOSCOPY DIAGNOSTIC PROCEDURE AND THE PATIENT WAS UNDER SEDATION. IT WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767003 ↗MalfunctionNov 20, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONO VIDEOSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED CONTAMINATION. THE DEVICE WAS RETESTED ON (B)(6) 2024, AND IT TESTED POSITIVE FOR 1 CFUS OF KLEBSIELLA PNEUMONIAE. THE DEVICE WAS TESTED AGAIN ON (B)(6) 2024 AND TESTED POSITIVE FOR MORE THAN 80 CFUS OF KLEBSIELLA PNEUMONIAE. THE DEVICE WAS TESTED AGAIN ON (B)(6) 2024 AND TESTED POSITIVE FOR MORE THAN 100 CFUS OF KLEBSIELLA PNEUMONIAE. 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 20740957 ↗MalfunctionOct 22, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR >80 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA, DELFTIA ACIDOVORANS, AND PERIBACILLUS SIMPLEX. 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 20507009 ↗MalfunctionOct 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPES NOZZLE (INSUFFLATION CHANNEL) WAS CLOGGED WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434401 ↗MalfunctionOct 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A WHITE FOREIGN MATERIAL FOUND INSIDE THE AIR/WATER CHANNEL AND THE JET TUBE CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351040 ↗MalfunctionSep 24, 2024Melted; Failure to Clean Adequately; Melted; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA III COLONOVIDEOSCOPE EXHIBITED PLASTIC DISTAL END COVER HAS BURN, FOREIGN OBJECTS IN BENDING SECTION COVER AND PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297065 ↗MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242431 ↗MalfunctionSep 12, 2024Failure to Clean Adequately; Failure to Clean Adequately
DURING THE DEVICE INSPECTION, IT WAS OBSERVED THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND THE AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202096 ↗MalfunctionAug 28, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE BENDING SECTION COVER OR DISTAL SHEATH RUBBER AND DISTAL END COVER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20092790 ↗MalfunctionAug 27, 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 AND THE AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20077093 ↗MalfunctionAug 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20061155 ↗MalfunctionAug 12, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 5 COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS WARNERI. 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 19964601 ↗MalfunctionAug 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COLONOVIDEOSCOPE HAD FOREIGN MATERIAL IN THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921453 ↗MalfunctionAug 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONO VIDEOSCOPE EXHIBITED INSTRUMENT CHANNEL WAS CLOGGED BY FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19920048 ↗MalfunctionJul 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON AIR/WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834331 ↗MalfunctionJul 17, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 3 COLONY FORMING UNITS (CFUS) OF HAFNIA ALVEI. 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 19760899 ↗MalfunctionJul 17, 2024Microbial Contamination of Device; Microbial Contamination of Device
CORRECTION OF THE INITIAL REPORT. THE USER PROVIDED THIRD-PARTY CULTURE TESTS WERE AS FOLLOWS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: ALL CHANNELS. CFU:>100COLONY FORMING UNITS (CFU)/ENDOSCOPE. BACTERIAL IDENTIFICATION: PSEUDOMONAS AERUGINOSA,KLEBSIELLA SP,KLEBSIELLA PNEUMONIAE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760088 ↗MalfunctionJul 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL WITHIN THE CONNECTING TUBE, JET TUBE, PROBE COVER IN BETWEEN THE CRACKS AND AROUND THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19751429 ↗MalfunctionJul 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE PLASTIC DISTAL END COVER AND AT THE END OF THE CAMERA HEAD CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749962 ↗MalfunctionJul 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE AIR/WATER TUBE AND CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690135 ↗MalfunctionJul 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED RESIDUAL WHITISH FOREIGN MATERIAL INSIDE THE AIR/ WATER JET TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19681020 ↗MalfunctionJul 3, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 6 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA IN THE SUCTION CHANNEL ON 17JUN2024. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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 19668716 ↗
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-1213-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-HQ190L.
- Z-1212-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190TL.
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 · 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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