COLONOVIDEOSCOPE CF-Q150I (UDI 04953170229473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170229473), received between Dec 22, 2019 and Sep 25, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Display/Image

  The customer reported that no image was displayed with the colonovideoscope during reprocessing. During the initial evaluation of the device, image blackout was observed. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898172 ↗
• MalfunctionDec 12, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE COLOVIDEOSCOPE HAD DIRTY OBJECTIVE LENS AND LIGHT GUIDE LENS. THE ISSUE HAD OCCURRED DURING SERVICE/MAINTENANCE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787386 ↗
• MalfunctionDec 8, 2025Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752535 ↗
• MalfunctionJul 17, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED ELECTRONICAL CONNECTOR PART WAS CRYSTALIZED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537958 ↗
• MalfunctionJul 18, 2020Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(6), IT WAS FOUND THAT THERE WAS FOREIGN MATERIAL ON THE CHANNEL OF THE SUBJECT DEVICE DUE TO THE DAMAGED CHANNEL. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293157 ↗
• InjuryDec 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE USER FACILITY NOTICED THE INTESTINAL PERFORATION OF THE PATIENT DURING THE COLONOSCOPY. THE USER FACILITY OPERATED THE LAPAROSCOPIC PROCEDURE AND TREATED THE INTESTINAL PERFORATION FOR THE PATIENT. AFTER THE TREATMENT, THE PATIENT RECOVERED WELL AND LEFT THE USER FACILITY WITHOUT ANY ADVERSE REACTIONS.

  Patient problems: Perforation

  MAUDE report 9508730 ↗