EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL (UDI 04953170307706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170307706), received between Aug 28, 2020 and Apr 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 reports).

2 FDA recall records name this device's identifier, 2 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. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1208-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Erratic or Intermittent Display; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A NOISY AND INTERMITTENT IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817945 ↗
• MalfunctionMar 31, 2026Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE PRESENTED DISTURBED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742026 ↗
• MalfunctionJan 2, 2026Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23948253 ↗
• MalfunctionSep 18, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247477 ↗
• MalfunctionAug 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE A CABLE WAS IDENTIFIED TO BE EXPOSED ON THE DISTAL TIP OF THE SCOPE. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10466085 ↗