EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190L (REF N3802541)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 is an Olympus EVIS EXERA III colonoscope, a flexible endoscope. Many of the 84 reports describe the scope not being cleaned adequately during reprocessing, while others describe no image, communication errors, stained images and foreign objects found during checks. The reports include no deaths and no injuries, and none describe patient involvement. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 04953170436659), received between May 5, 2023 and Sep 29, 2026 — classified as 86 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (51 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 Adequately51
- Communication or Transmission Problem12
- Device Reprocessing Problem9
- Microbial Contamination of Device4
- No Display/Image4
- Break2
- Poor Quality Image2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions86
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026No Display/Image; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941334 ↗MalfunctionSep 18, 2026No Display/Image; Communication or Transmission Problem
It was reported that during a diagnostic colonoscopy, the colonovideoscope experienced a B30 error message and the image disappeared. The reported event resulted in a procedural prolongation of less than 30 minutes. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826888 ↗MalfunctionDec 27, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903259 ↗MalfunctionDec 8, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD AN E237 ERROR (SCOPE ERROR) AND AN E226 ERROR (SCOPE COMMUNICATION ERROR). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743527 ↗MalfunctionNov 12, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NOT DISPLAY IMAGE. THE EVENT OCCURRED DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538506 ↗MalfunctionOct 31, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED A STAINED IMAGE; THE ISSUE OCCURRED DURING THE SERVICE OR MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441230 ↗MalfunctionMar 11, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE AIR/WATER CYLINDER AND TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575394 ↗MalfunctionDec 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903124 ↗MalfunctionDec 6, 2024Contamination; Contamination
IT WAS REPORTED THAT PRESENCE OF A WHITE POWDER SLIPPED UNDER THE RUBBER ON THE COLONOVIDEOSCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20870789 ↗MalfunctionDec 4, 2024Device Reprocessing Problem; Obstruction of Flow; Device Reprocessing Problem; Obstruction of Flow
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849958 ↗MalfunctionNov 22, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN UNSUPPORTED SCOPE AND THE SCOPE WAS NOT TAKING ANY PICTURES. THE EVENT OCCURRED DURING A COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758072 ↗MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE HAD AN UNSPECIFIED AIR/WATER FLOW ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20631767 ↗MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT FOREIGN MATERIAL WAS FOUND IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630462 ↗MalfunctionOct 29, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT EXHIBITED WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555824 ↗MalfunctionOct 15, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE JET TUBE OF THE COLONOVIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454290 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THE ADHESIVE WAS STUCK INSIDE THE BIOPSY CHANNEL OF THE COLONOVIDEOSCOPE. THIS OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427750 ↗MalfunctionOct 10, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/ WATER NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421066 ↗MalfunctionOct 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385184 ↗MalfunctionOct 4, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD AN ERROR CODE E315 (INCOMPATIBLE SCOPE). THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20367751 ↗MalfunctionOct 2, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE COLONOVIDEOSCOPE HAD E315 SCOPE ERROR. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353347 ↗MalfunctionSep 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE BENDING SECTION COVER AND THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303908 ↗MalfunctionSep 25, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONO VIDEOSCOPE 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 20298503 ↗MalfunctionSep 17, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE COLONOVIDEOSCOPE HAD E216 AND E315 COMMUNICATION PROBLEM ERRORS. THE ISSUE OCCURRED WHEN TAKING THE DEVICES OUT OF THE BOXES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242592 ↗MalfunctionSep 17, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately
CORRECTION TO B5 OF THE INITIAL REPORT. THERE WAS NO BURN ON THE PLASTIC DISTAL END COVER OBSERVED DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235907 ↗MalfunctionSep 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL AT THE AIR/WATER TUBE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223594 ↗
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-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- 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-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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