EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190I (REF N3802641)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170436673), received between Oct 23, 2023 and Nov 19, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED THE NOZZLE OF THE INSUFFLATION CHANNEL IS CLOGGED BY AN ORGANIC RESIDUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722584 ↗
• MalfunctionNov 6, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621430 ↗
• MalfunctionSep 11, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE FLEX VIDEOSCOPE TESTED POSITIVE FOR 14 COLONY FORMING UNITS (CFUS) OF ENTEROBACTERIIACEAE. 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 20187207 ↗
• MalfunctionSep 10, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185157 ↗
• MalfunctionJul 26, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THE COLONOVIDEOSCOPE LIGHT GUIDE LENS HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839862 ↗
• MalfunctionJun 14, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 23 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA AND PSEUDOMONAS HOMINIS. THE SUCTION CHANNEL TESTED POSITIVE FOR 21 CFUS OF PSEUDOMONAS HOMINIS, AND THE AXILLARY CHANNEL TESTED POSITIVE FOR 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 19538283 ↗
• MalfunctionJun 12, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522140 ↗
• MalfunctionJun 4, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE FLEX VIDEO SCOPE BENDING SECTION COVER AND CONNECTING TUBE HAD FOREIGN OBJECTS, NOZZLE WAS CLOGGED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462869 ↗
• MalfunctionJan 30, 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 ROUTINE MICROBIOLOGICAL CULTURE OF THE SCOPE DURING REPROCESSING. 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 18610440 ↗
• MalfunctionJan 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE HAD E315 ERROR (INCOMPATIBLE SCOPE). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489258 ↗
• MalfunctionJan 9, 2024Failure to Clean Adequately; Failure to Clean Adequately

  A USER FACILITY RETURNED THE OLYMPUS ASSET, COLONOVIDEOSCOPE, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT FOREIGN OBJECTS WERE ON/ IN THE: AIR/ WATER CYLINDER, JET TUBE, AND AIR/ WATER TUBE. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477530 ↗
• MalfunctionDec 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE OLYMPUS ASSET DEVICE COLONOVIDEOSCOPE WAS RETURNED WITH NO COMPLAINT REPORTED BY THE USER. DURING INSPECTION AND TESTING, THE AIR/WATER TUBE AND CYLINDER HAD FOREIGN OBJECTS. 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 18359974 ↗
• MalfunctionNov 8, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III COLONOVIDEOSCOPE HAD A HALO ON THE IMAGE. THIS ISSUE WAS FOUND DURING CUSTOMER REPROCESSING. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER CYLINDER AND IN THE AIR/WATER TUBE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095209 ↗
• MalfunctionOct 23, 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 SCOPE WAS SAMPLED TWICE. DURING THE FIRST SAMPLING, THE SCOPE TESTED POSITIVE FOR 58 COLONY FORMING UNITS (CFUS) OF SAPROPHYTES. DURING THE SECOND SAMPLING, THE SCOPE TESTED POSITIVE FOR 20 CFUS OF SAPROPHYTES. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. ALL CHANNELS WERE TESTED. 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 17991798 ↗

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-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-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-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