EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190I (REF N3802841)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170436710), received between Dec 19, 2023 and Jul 16, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 60 COLONY FORMING UNITS (CFUS) OF AEROBIC MESOPHILIC FLORA AND 1 CFU OF AN INDICATOR MICRO-ORGANISM, IDENTIFYING THE BACTERIA ACINETOBACTER IWOFFII. 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 19756370 ↗
• MalfunctionJul 11, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE COLONOVIDEOSCOPE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, THE COLONOVIDEOSCOPE¿S AIR/WATER (A/W) TUBE AND A/W CYLINDER HAD FOREIGN MATERIAL. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727342 ↗
• MalfunctionMar 12, 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 SERRATIA MARCESCENS. 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 18891362 ↗
• MalfunctionDec 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE EXPERIENCED AN IMAGE ISSUE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, WHITE FOREIGN MATERIAL WAS FOUND IN THE AIR WATER TUBE AND CYLINDER. 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 18360499 ↗

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-0419-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0417-2024 · Oct 16, 2023 · Open, Classified
  GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0418-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0416-2024 · Oct 16, 2023 · Open, Classified
  GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• 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