EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (UDI 04953170307720)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170307720), received between Jan 14, 2021 and Dec 5, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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-1214-2024 · 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025No Display/Image; Poor Quality Image; Failure to Clean Adequately; No Display/Image; Poor Quality Image; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED IMAGE DISTORTION (A NOISE IMAGE), NO IMAGE, FOREIGN OBJECTS COME OUT OF AIR/WATER CYLINDER, IMAGE GUIDE PROTECTOR IS DIRTY, SCOPE-CONNECTOR IS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727764 ↗
• MalfunctionNov 25, 2025Melted; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLON VIDEOSCOPE EXHIBITED BURNED PLASTIC ON THE DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648749 ↗
• MalfunctionOct 9, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407266 ↗
• MalfunctionMay 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE AIR CHANNEL WAS UNABLE TO WORK DUE TO A CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235021 ↗
• MalfunctionMar 10, 2021Partial Blockage; Partial Blockage

  IT IS REPORTED WHILE PRE-CLEANING OF AN EVIS EXERA II COLONOVIDEOSCOPE, A CLIP WAS DISLODGED FROM THE INSTRUMENT CHANNEL. THERE WAS NO PATIENT CONTACT/IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453815 ↗
• MalfunctionJan 14, 2021Partial Blockage; Device Reprocessing Problem; Material Twisted/Bent; Partial Blockage; Device Reprocessing Problem; Material Twisted/Bent

  IT IS REPORTED WHILE PREPARING AN EVIS EXERA II COLONOVIDEOSCOPE FOR USE, BLACK SPECS CAME OUT OF THE DEVICE WHEN IT WAS HOOKED UP TO A DRYER. THERE WAS NO PATIENT CONTACT/IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 11174013 ↗