EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL (UDI 04953170202445)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04953170202445), received between Aug 4, 2020 and Mar 4, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (17 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN SUCTION CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510729 ↗
• MalfunctionFeb 18, 2026Erratic or Intermittent Display; No Device Output

  IT WAS REPORTED THAT THE COLONVIDEOSCOPE HAD AN ISSUE WHERE THE IMAGE WAS FLICKERING ON AND OFF AND THE LAMP WAS NOT ILLUMINATING. THE ISSUE OCCURRED DURING A DIAGNOSTIC UPPER ENDOSCOPY PROCEDURE, WHICH WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377299 ↗
• MalfunctionDec 29, 2025Microbial Contamination of Device; Microbial Contamination of Device

  NO NEW INFORMATION RECEIVED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905668 ↗
• MalfunctionDec 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL EXITING FROM THE CHANNEL (INCLUDING AUXILIARY WATER CHANNEL). THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852179 ↗
• MalfunctionNov 5, 2024Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  IT WAS REPORTED THE COLONOVIDEOSCOPE HAD BURNING AND MELTING OF THE PLASTIC DISTAL END COVER AT THE FORCEPS PORT. IT IS UNSPECIFIED WHEN THIS ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609393 ↗
• MalfunctionSep 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279265 ↗
• MalfunctionSep 18, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE SWITCH AND SWITCH BOX AS WELL AS ON THE UP/DOWN AND RIGHT/LEFT KNOBS. FOREIGN MATERIAL COME OUT FROM THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250059 ↗
• MalfunctionAug 22, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT WHILE CONDUCTING THE FACILITY REVIEW SUMMARY ON THE EVIS EXERA II COLONOVIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039210 ↗
• MalfunctionMay 6, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE ADHESIVE ON THE BENDING SECTION COVER AND THE BENDING SECTION COVER OF THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247848 ↗
• MalfunctionMar 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855335 ↗
• MalfunctionMar 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854947 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852746 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852037 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851875 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851755 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849950 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849099 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848774 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848772 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848279 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847592 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846774 ↗
• MalfunctionMar 6, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE ENDOSCOPE WAS INCORRECTLY REPROCESSED. THE SCOPE WAS REPROCESSED USING AN ENDOSCOPE REPROCESSOR, WHERE THE INTERNAL AIR AND WATER FILTERS HAD NOT BEEN REPLACED SINCE THE DATE OF INSTALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846126 ↗
• MalfunctionDec 22, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II COLONOVIDEOSCOPE HAD AN ANGULATION WIRE AND UP/DOWN KNOB ISSUE. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE BENDING SECTION COVER 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 18382822 ↗
• MalfunctionNov 24, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE OLYMPUS FIELD SERVICE ENGINEER (ON BEHALF OF THE CUSTOMER) REPORTED TO OLYMPUS THAT THE COLONOVIDEOSCOPE HAD ANGULATION PLAY AND NOT ENOUGH AND INSERTION TUBE DISCOLORED/STAIN/WRINKLED. CUSTOMER FOUND THE PROBLEM IN THEIR REPROCESSING TIME. NEEDED DETAILED INSPECTION OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOUND THE SCOPE HAD FOREIGN OBJECTS IN THE FOLLOWING PARTS: THE PLASTIC DISTAL END COVER, BENDING SECTION COVER AND IN THE CONNECTING TUBE. 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 18206370 ↗