COLONOVIDEOSCOPE OLYMPUS CF-LV1LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170312397), received between Jan 25, 2022 and Nov 12, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE FLEX VIDEO SCOPE HAD IMAGE LOSS. IMAGE DISAPPEARED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668223 ↗
• MalfunctionJun 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THERE WAS FOREIGN MATERIAL IN THE NOZZLE OF THE COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555099 ↗
• MalfunctionJun 10, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE NOZZLE AND DISTAL END COVER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500267 ↗
• MalfunctionDec 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE COLONOVIDEOSCOPE HAD REDUCED ANGULATION/PLAY IN SCOPE. THE ISSUE WAS FOUND DURING GENERAL ROUTINE INSPECTION BY THE CUSTOMER. THE OLYMPUS FIELD SERVICE ENGINEER CONFIRMED THE DEVICE WAS REPROCESSED AT THE CUSTOMER SITE, BEFORE PICK UP. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE FOUND: NOZZLE, ADHESIVE AROUND OBJECTIVE LENS, AND THE BENDING SECTION COVER ALL HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM. 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 18406790 ↗
• MalfunctionNov 9, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE OLYMPUS FIELD SERVICE ENGINEER REPORTED (ON BEHALF OF THE CUSTOMER) THAT THERE WAS NO UPWARD/DOWNWARD ANGULATION ON THE COLONOVIDEOSCOPE. THE ISSUE WAS FOUND DURING AN UNSPECIFIC PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE BENDING SECTION COVER HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM. 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 18107151 ↗
• MalfunctionAug 8, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS MEDICAL THAT THE COLONOVIDEOSCOPE HAD A WRINKLED, DISCOLORED CONNECTOR TUBE, AN LED ISSUE AND LOW ANGULATION CONTROL. THE CUSTOMER REPORTED THE ISSUE WAS FOUND DURING MAINTENANCE. THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER NOZZLE AND CONNECTOR TUBE AND THE ADHESIVE ON THE BENDING SECTION COVER WAS DIRTY. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482394 ↗
• MalfunctionMay 24, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE COLONOVIDEOSCOPE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, A YELLOWISH/BROWN FOREIGN OBJECT WAS FOUND IN THE NOZZLE. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995030 ↗
• MalfunctionMar 31, 2022Contamination; Contamination

  THE USER FACILITY REPORTED TO OLYMPUS DURING PREPARATION FOR USE, SCOPE LED WAS NOT WORKING ON THE COLONOVIDEOSCOPE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. DURING THE EVALUATION OF THE RETURNED DEVICE, A FOREIGN MATERIAL WAS OBSERVED INSIDE THE AIR/WATER NOZZLE. THIS REPORT IS BEING SUBMITTED AS AN MDR BASED ON REPORTABLE MALFUNCTION OBSERVED DURING THE EVALUATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959534 ↗
• MalfunctionMar 30, 2022Contamination; Contamination

  CUSTOMER RETURNED THE DEVICE FOR INSPECTION. THERE IS NO REPORTED HARM TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE NOZZLE HAD FOREIGN MATERIAL. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF FOREIGN MATERIAL FOUND IN THE NOZZLE DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955568 ↗
• MalfunctionJan 25, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE USER FACILITY REPORTED TO OLYMPUS THE COLONOVIDEOSCOPE HAD PLAY IN UPWARD/DOWNWARD ANGULATION CONTROL KNOB, LEAKAGE FROM THE BIOPSY CHANNEL, THE COAT WAS PEELING, BENDING MANIPULATION AND INSERTION TUBE DEFECTS. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE NOZZLE HAD FOREIGN MATERIAL WHICH OCCURRED FROM INSUFFICIENT CLEANING. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING ESTIMATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13347739 ↗