EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (UDI 04953170339172)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170339172), received between Oct 28, 2021 and Oct 31, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE ETHYLENE OXIDE (GAS) VALVE OF THE COLONOVIDEOSCOPE LEFT OFF. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439609 ↗
• MalfunctionOct 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A BURN ON THE DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453668 ↗
• MalfunctionOct 14, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED 3 TIMES POSITIVE FOR PSEUDOMONAS. 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 20446347 ↗
• MalfunctionAug 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE AIR/WATER CYLINDER, AIR/WATER TUBE AND JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086320 ↗
• MalfunctionApr 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154652 ↗
• MalfunctionFeb 27, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED THE LIGHT GUIDE AND OBJECTIVE LENSES ADHESIVES HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18792997 ↗
• MalfunctionFeb 20, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER TUBE, AIR/WATER CYLINDER, JET-TUBE AND CONNECTING TUBE. IN ADDITION, THE ADHESIVE ON THE BENDING SECTION COVER HAD FOREIGN MATERIAL ATTACHED IN THE EDGES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744409 ↗
• MalfunctionFeb 1, 2024Device Reprocessing Problem; Device Reprocessing Problem

  DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE WAS FOUND TO HAVE FOREIGN MATERIAL ON OR IN THE AIR/WATER TUBE AND CYLINDER AND THE AUXILIARY JET CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627317 ↗
• MalfunctionJan 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE EVIS EXERA II COLONOVIDEOSCOPE HAD A ISSUE WITH THE TIE ROD. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND AND NO PROCEDURE INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE ADHESIVE AROUND THE OBJECTIVE LENS 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 18517633 ↗
• MalfunctionSep 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT EVIS EXERA II COLONOVIDEOSCOPE THAT THE BOWDEN CABLE REQUIRED ADJUSTMENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE AUXILIARY 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 17778126 ↗
• MalfunctionOct 28, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED BY THE CUSTOMER, THE INFECTED (UNWASHED) EVIS EXERA II COLONOVIDEOSCOPE PRESENTED A BLACK STRIP IN THE IMAGE. NO PATIENT HARM REPORTED. OLYMPUS SENT THE DEVICE TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. THE AUXILIARY WATER CHANNEL TESTED POSITIVE FOR ONE (1) COLONY FORMING UNIT (CFU) OF STAPHYLOCOCCUS WARNERI. THE SCOPE WAS SAMPLED AGAIN WHICH RESULTED IN A NEGATIVE TEST. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE POSITIVE CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712463 ↗