EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190L (REF N3802741)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170436697), received between Jul 12, 2023 and Mar 19, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (4 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORRODED INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640978 ↗
• MalfunctionOct 24, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER-CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521553 ↗
• MalfunctionSep 18, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED AIR/WATER TUBE AND AIR/WATER CYLINDER HAD FOREIGN MATERIAL, AND DUE TO BURN ON PLASTIC DISTAL END COVER, INSULATION RESISTANCE VALUE AT DISTAL END DOES NOT MEET THE STANDARD VALUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247555 ↗
• MalfunctionAug 20, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE FAILED MULTIPLE REPROCESSING ATTEMPTS FOR WATER BLOCKAGE, WHICH CAUSED THE DEVICE TO BE INSUFFICIENTLY OR INCORRECTLY REPROCESSED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008944 ↗
• MalfunctionMar 25, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE CUSTOMER DEVIATED FROM THE INSTRUCTIONS FOR USE (IFU) FOR THE COLONOVIDEOSCOPE DURING REPROCESSING OF THE DEVICE ON MULTIPLE OCCASIONS. THERE WERE NO REPORTS OF PATIENT HARM OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18972546 ↗
• MalfunctionMar 4, 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 18828139 ↗
• MalfunctionFeb 28, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE COLONOVIDEOSCOPE HAD PROBLEMS RELATED TO REPROCESSING. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796830 ↗
• MalfunctionFeb 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE AIR/WATER (A/W) TUBE AND CYLINDER HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718519 ↗
• MalfunctionNov 16, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE COLONOVIDEOSCOPE HAD AN INSUFFLATION PROBLEM. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, THE AIR/WATER NOZZLE (INSUFFLATION CHANNEL) WAS CLOGGED BY A SOLID CHEMICAL RESIDUE 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 18151574 ↗
• MalfunctionJul 12, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE LOANER EVIS EXERA III COLONOVIDEOSCOPE GAVE AN E315-SCOPE COMMUNICATION ERROR. THIS OCCURRED DURING PREPARATION FOR USE FOR AN EXAMINATION. AFTER STERILIZING THE INSTRUMENT AND ATTACHING IT TO THE COLUMN, THE ERROR OCCURRED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309646 ↗

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, Classified
  Colonoscope, Model Number PCF-H190DL.
• Z-0416-2024 · Oct 16, 2023 · Open, Classified
  GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0418-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0415-2024 · Oct 16, 2023 · Open, Classified
  CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
• Z-0417-2024 · Oct 16, 2023 · Open, Classified
  GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0419-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0341-2024 · Sep 25, 2023 · Open, Classified
  Colonoscope-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, Classified
  EVIS 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