HALOGEN LIGHT SOURCE CLH-250 (UDI 04953170024412)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170024412), received between Jan 21, 2021 and Sep 24, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THE LAMP ON THE HALOGEN LIGHT SOURCE DID NOT LIGHT UP. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297067 ↗
• MalfunctionOct 11, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE HAD THE LAMP NOT COME ON WHEN THE POWER DID. THE ISSUE OCCURRED DURING PREPARATION FOR USE AND THE PROCEDURE THAT WAS DONE WAS DELAYED BY A DAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17910628 ↗
• MalfunctionOct 9, 2023Output Problem; Poor Visibility; Output Problem; Poor Visibility

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT, ALTHOUGH THE ENDOSCOPIC IMAGE COULD STILL BE SEEN, THEIR HALOGEN LIGHT SOURCE PRODUCED A DIMMER THAN USUAL BRIGHTNESS CURING AN UNKNOWN PROCEDURE. THE DIMNESS WAS DESPITE THE RECENT INSTALLATION OF A NEW BULB. THE CUSTOMER LATER REPORTED ON (B)(6) 2023 THAT IT WAS DIFFICULT TO VISUALIZE THE INTERNAL STRUCTURE OF THE BLADDER AS WELL AS STENTS DURING STENT REMOVALS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION REVEALED FOLLOWING THE RECEIPT OF ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902074 ↗
• MalfunctionOct 29, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE HALOGEN LIGHT SOURCE LAMP FAILS TO LIGHT. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697270 ↗
• MalfunctionOct 18, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED THE HALOGEN LIGHT SOURCE FAILS TO WORK. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621221 ↗
• MalfunctionAug 16, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE HALOGEN LIGHT SOURCE MAIN LAMP FAILS TO LIGHT. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237338 ↗
• MalfunctionAug 5, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT DURING MAINTENANCE ON HIS OLYMPUS HALOGEN LIGHT SOURCE, THE FAN WAS FOUND NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180487 ↗
• MalfunctionJun 27, 2022Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE LIGHT SOURCE WAS NOT FUNCTIONING. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. UPON INSPECTION OF THE DEVICE AT THE USER FACILITY, PERFORMED BY AN OLYMPUS FIELD SERVICE ENGINEER, IT WAS DETERMINED THE LAMP FAILED TO IGNITE DUE TO A FUSE ISSUE. THIS REPORT IS SUBMITTED DUE TO THE THE REPORT OF LAMP FAILED TO IGNITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14832126 ↗
• MalfunctionMay 18, 2022Communication or Transmission Problem; Material Deformation; Communication or Transmission Problem; Material Deformation

  THE CUSTOMER ORIGINALLY RETURNED THEIR OLYMPUS HALOGEN LIGHT SOURCE HAS THE LAMP WAS NOT WORKING EVEN AFTER IT WAS REPLACED. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT THE LAMP SOCKET HAD DETERIORATED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE CONFIRMED DETERIORATED LAMP SOCKET NOTED DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427514 ↗
• MalfunctionApr 28, 2022Failure to Power Up; Failure to Power Up

  THE USER FACILITY REPORTED THE SUBJECT DEVICE WAS "DEAD", THERE WAS NO LIGHT AND NO FAN. THE INTENDED DIAGNOSTIC PROCEDURE WAS CANCELLED. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE ISSUE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239499 ↗
• MalfunctionJan 21, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THE CUSTOMER WAS EXPERIENCING A "DIM LIGHT" WITH THE OLYMPUS HALOGEN LIGHT SOURCE. NO INFORMATION REGARDING PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Information

  MAUDE report 11211299 ↗