EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI (UDI 04953170339592)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170339592), received between Jun 19, 2018 and Jul 30, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (6 reports).

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.

• MalfunctionJul 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED DIRT ON THE OBJECTIVE LENS AND FOREIGN MATERIAL IN THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860067 ↗
• MalfunctionDec 11, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE COLONOVIDEOSCOPE HAD NO AIR/WATER FLOW. DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE NOZZLE IS CLOGGED BY A BLACK RUBBERY MATERIAL. THERE WAS NO REPORT 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 18303841 ↗
• MalfunctionNov 21, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE EXPERIENCED LIGHT PROBLEM. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE JET TUBE WAS FOUND WITH 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 18185589 ↗
• MalfunctionNov 17, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE HAD A BLURRY IMAGE. THE ISSUE WAS FOUND DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF DELAYS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE JET TUBE HAD FOREIGN MATERIAL. 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 18161874 ↗
• MalfunctionSep 26, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II COLONOVIDEOSCOPE HAD AN UNSPECIFIED COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: A WHITISH FOREIGN MATERIAL WAS INSIDE OF THE JET TUBE RESEMBLING TRACES FROM A SOLUTION THAT DRIED. 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 17818508 ↗
• MalfunctionSep 26, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II COLONOVIDEOSCOPE HAD AN UNSPECIFIED COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE JET TUBE HAD A WHITISH FOREIGN MATERIAL. 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 17818359 ↗
• MalfunctionSep 1, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II COLONOVIDEOSCOPE HAD A POOR LIGHT OUTPUT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE AUXILIARY CHANNEL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION (FOREIGN MATERIAL). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670277 ↗
• MalfunctionAug 2, 2023Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED TO OLYMPUS, THAT THE EVIS EXERA II COLONOVIDEOSCOPE HAD NO LENS WASHING. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY AND IT WAS COMPLETED WITH THE SAME DEVICE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE NOZZLE WAS CLOGGED WITH FOREIGN MATERIAL RESEMBLING BLACK RUBBER. THERE WERE NO REPORTS HARM ASSOCIATED WITH THE 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 17442434 ↗
• MalfunctionFeb 18, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, SUCTION CHANNEL, AIR/WATER CHANNEL AND ALL CHANNELS OF THE EVIS EXERA II COLONOVIDEOSCOPE TESTED POSITIVE FOR PSEUDOMONAS FLUORESCENS, ACTINOBACILLUS UREAE, STAPHYLOCOCCUS EPIDERMIDIS AND SERRATIA MARCESCENS . THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE ON (B)(6), 2022. 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 13559498 ↗
• MalfunctionJun 19, 2018Leak/Splash; Leak/Splash

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A POLYPECTOMY USING THE SUBJECT DEVICE, FINE DARK GREY GRAPHITE POWDER LEAKED OUT FROM THE SUBJECT DEVICE AND FELL OFF WITHIN THE BOWEL OF THE PATIENT. IT WAS ALSO REPORTED THAT THE POWDER FELL OFF FROM THE SUBJECT DEVICE AND AIR LEAKAGE WAS NOTED DURING THE CLEANING PROCESS AFTER THE PROCEDURE. THERE WAS NO OTHER DETAILED INFORMATION ABOUT THE EVENT, BUT THERE WAS NO PATIENT INJURY REPORT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7612920 ↗