COLONOVIDEOSCOPE OLYMPUS CF-LV1IRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170312410), received between Jul 6, 2022 and Mar 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE NOZZLE AND BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836876 ↗
• MalfunctionDec 19, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE EXHIBITED AIR/WATER FEEDING PROBLEM. THE ISSUE WAS FOUND DURING AN ENTEROSCOPY PROCEDURE. THE PATIENT WAS NOT UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS RETURNED AND AN EVALUATION REVEALED, THE DISTAL END OF THE DEVICE WAS DIRTY. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003193 ↗
• MalfunctionOct 14, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE SUBJECT DEVICE EXHIBITED INSUFFICIENT AIR/WATER SUPPLY. THE REPORTED ISSUE OCCURRED DURING INSPECTION OF THE SUBJECT DEVICE, PRIOR TO AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT A DELAY. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE NOZZLE WAS CLOGGED WITH SOME RUBBER-LIKE FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610755 ↗
• MalfunctionAug 2, 2022Obstruction of Flow; Obstruction of Flow

  A USER FACILITY REPORTED TO OLYMPUS THAT AIR/WATER WOULD NOT FLOW DUE TO INSUFFICIENT OR INCORRECT REPROCESSING OF THE SCOPE. THE PROBLEM OCCURRED DURING AN ENTEROSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE WITH NO DELAY IN PROCEDURE REPORTED. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149728 ↗
• MalfunctionJul 19, 2022Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately

  A USER FACILITY REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE HAD AIR/WATER FLOW PROBLEM. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO AN ENTEROSCOPY PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE WITH NO DELAYED. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, FIBROUS FOREIGN MATERIAL WAS FOUND CLOGGED IN THE SCOPE NOZZLE DUE TO INSUFFICIENT OR INCORRECT REPROCESSING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053481 ↗
• MalfunctionJul 6, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE SUBJECT DEVICE EXHIBITED REDUCED ANGULATION AND ISSUES WITH THE AIR/WATER FLOW. THE REPORTED ISSUE OCCURRED WHILE PREPARING THE SUBJECT DEVICE FOR USE, PRIOR TO A DIAGNOSTIC ENTEROSCOPY. THE INTENDED PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PROCEDURE DELAY. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, FOREIGN MATERIAL WAS OBSERVED ON/AROUND THE OBJECTIVE LENS AND THE AIR/WATER NOZZLE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (FOREIGN MATERIAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935694 ↗