EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (UDI 04953170339882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170339882), received between Aug 8, 2023 and Dec 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE AIR/WATER CHANNEL OF THE COLONOVIDEOSCOPE HAD WHITE RESIDUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790237 ↗
• MalfunctionJan 29, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595550 ↗
• MalfunctionJan 14, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE HAD AN ANGULATION MALFUNCTION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THERE WAS A FOREIGN MATERIAL IN THE AIR/WATER TUBE, THE AIR/WATER CYLINDER AND IN THE AUXILIARY JET CHANNEL. 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 18509615 ↗
• MalfunctionJan 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  A USER FACILITY RETURNED THE OLYMPUS ASSET, EVIS EXERA II COLONOVIDEOSCOPE TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE THE A/W (AIR/WATER) TUBE AND CYLINDER HAD FOREIGN MATERIALS AND THE J-TUBE (JET TUBE) WAS CLOGGED WITH FOREIGN MATERIAL. 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 18432053 ↗
• MalfunctionOct 30, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER RETURNED THE EVIS EXERA II COLONOVIDEOSCOPE, FOR THE ANNUAL INSPECTION WITHOUT REPORTING ANY ISSUES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE AIR/WATER TUBE AND AIR/WATER CYLINDER HAD FOREIGN MATERIAL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031932 ↗
• MalfunctionOct 20, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II COLONOVIDEOSCOPE HAD A BROKEN BODY CONTROL UNIT RUBBER. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: AIR OR WATER CYLINDER HAD FOREIGN OBJECTS. 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 17980866 ↗
• MalfunctionAug 8, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II COLONOVIDEOSCOPE WAS DUE FOR AN ANNUAL INSPECTION. NO PATIENT HARM WAS ASSOCIATED WITH THIS EVENT/REQUEST. THE DEVICE WAS RETURNED TO OLYMPUS FOR AN ANNUAL INSPECTION AND FOUND DUE TO DAMAGE THE ANGULATION BECOMES LOCKED AND CANNOT DISENGAGE, DUE TO DEFORMATION OF RIGHT/LEFT SPROCKET THE BENDING SECTION COULD NOT BE CONTROLLED AT ALL, AND THE RIGHT/LEFT HOLDS THE POSITION WITH NO AUTOMATIC RETURN. 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 17485153 ↗