EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180DIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170339639), received between Dec 11, 2023 and Aug 22, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionAug 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028678 ↗
• MalfunctionApr 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AUXILIARY JET TUBE, AIR/WATER-TUBE, AND AIR/WATER-CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168764 ↗
• MalfunctionMar 29, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER TUBE, CYLINDER AND JET TUB HAD FOREIGN OBJECTS ON THE VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002873 ↗
• MalfunctionDec 11, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE COLONOVIDEOSCOPE HAD A LEAKAGE AT SCOOP GUIDE. NO REPORTS OF PATIENT HARM. DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE JET TUBE HAD REMAINS OF WHITE 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 18302851 ↗