HALOGEN LIGHT SOURCE OLYMPUS CLK-4 (UDI 04953170024511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 04953170024511), received between Mar 14, 2019 and Jun 13, 2025 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE SUBJECT DEVICE HAD NO POWER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204522 ↗
• MalfunctionMar 18, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT THE LIGHT SOURCE PRESENTED A NO LIGHT PROBLEM WITH THE BULB DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635576 ↗
• MalfunctionJan 24, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE DID NOT LIGHT UP. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572015 ↗
• MalfunctionJan 15, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE COULD NOT BE SWITCHED ON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18512706 ↗
• MalfunctionJan 9, 2024Failure to Power Up; Component Missing; Failure to Power Up; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE LIGHT SOURCE FRONT PANEL WAS DAMAGED. THE CUSTOMER DID NOT KNOW HOW BUT THE FRONT CASING WAS SMASHED. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE POWER SWITCH WAS PUSHED INWARD AND THE SPARE LAMP WAS MISSING. 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 18478478 ↗
• MalfunctionJan 8, 2024Failure to Power Up; Failure to Power Up

  A USER FACILITY RETURNED THE OLYMPUS ASSET, THE HALOGEN LIGHT SOURCE, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE UNIT IS NOT TURNING ON DUE TO MISALIGNMENT OF THE TOP COVER. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465882 ↗
• MalfunctionJan 6, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE HAD LAMP LIGHTING ISSUES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461097 ↗
• MalfunctionDec 19, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THE LIGHT SOURCE HAS LAMP LIGHTING ISSUES. THE LIGHT SOURCE WAS TURNED ON, MADE A POPPING NOISE, AND STARTED SMOKING. THE CUSTOMER REPLACED THE BULB AND THE LIGHT SOURCE DID NOT WORK. IT IS UNKNOWN WHEN THIS ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359476 ↗
• MalfunctionNov 30, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE POWER SWITCH WAS FALLING OFF. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239782 ↗
• MalfunctionNov 22, 2023Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER WITH NO ALLEGED COMPLAINT. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, A FAULTY TRANSFORMER WAS FOUND AND THE SPARE LAMP WAS MISSING. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194585 ↗
• MalfunctionOct 17, 2023No Device Output; No Device Output

  THE OLYMPUS FIELD SERVICE ENGINEER (FSE) ON BEHALF OF THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE HAD NO POWER. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950434 ↗
• MalfunctionOct 1, 2023Loss of Power; Loss of Power

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS NOT WORKING (NO POWER) ON THE HALOGEN LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849545 ↗
• MalfunctionSep 5, 2023Component Missing; Component Missing

  IT WAS REPORTED TO OLYMPUS, THAT THE HALOGEN LIGHT SOURCE HAD A BROKEN HANDLE, DAMAGE TO THE HOOD ON TWO CORNERS, IGNITION WITH UNEXPECTED NOISE AND DEFORMED STRUCTURE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE SPARE LAMP WAS MISSING. THERE WERE NO REPORTS OF PATIENT HARM 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 17686322 ↗
• MalfunctionAug 15, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE HALOGEN LIGHT SOURCE POWER SWITCH WAS DAMAGED. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552290 ↗
• MalfunctionAug 14, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE HAD LAMP NOT IGNITING AND ABNORMAL SOUND PROBLEMS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540356 ↗
• MalfunctionJun 12, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE HOUSING WAS DEFECTIVE. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND THE SPARE LAMP WAS DAMAGED, AND CONNECTION PINS OF THE LAMP WERE BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113755 ↗
• MalfunctionMay 18, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE LAMP TO THE HALOGEN LIGHT SOURCE WAS NOT WORKING. IT WAS UNKNOWN, WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954002 ↗
• MalfunctionMay 12, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HALOGEN LIGHT SOURCE, THE LEAKAGE TESTER (MB-155) HAD A LEAK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921068 ↗
• MalfunctionApr 25, 2023No Device Output; No Device Output

  THE HALOGEN LIGHT SOURCE, MODEL NUMBER CLK-4 WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, THE DEVICE WOULD NOT TURN ON. 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 16811761 ↗
• MalfunctionApr 4, 2023Loss of Power; Loss of Power

  ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT WAS ASKED TO VISIT ANOTHER HOSPITAL; THE PROCEDURE WAS POSTPONED, BUT NO MORE INFORMATION IS KNOWN AS THE PATIENT WAS SHIFTED TO ANOTHER HOSPITAL. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA UNTIL HE REMAINED IN THE HOSPITAL BEFORE BEING ASKED TO VISIT ANOTHER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673471 ↗
• MalfunctionMar 29, 2023Failure to Power Up; Component Missing; Failure to Power Up; Component Missing

  A USER FACILITY REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE WAS OVER HEATING AND COULD NOT TURN ON. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE LIGHT SOURCE HAD BLOWN THERMAL FUSE WHICH RESULTED IN LIGHT FAILING TO LIGHT UP AND MISSING SPARE LAMP. 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 16639466 ↗
• MalfunctionFeb 10, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE FRONT PANEL OF THE HALOGEN LIGHT SOURCE WAS BROKE/DAMAGED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT HARM OR IMPACT REPORTED. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE CONFIRMED THE FRONT PANEL WAS BROKEN OFF, AND FOUND THAT THE SPARE LAMP WAS MISSING. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16355439 ↗
• MalfunctionFeb 8, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING HALOGEN LIGHT SOURCE WAS IMPOSSIBLE TO START IT; THERE WAS NO LIGHT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT, HOWEVER A RESPONSE HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324650 ↗
• MalfunctionJan 31, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT THE LAMP ON HIS OLYMPUS HALOGEN LIGHT SOURCE WAS NOT POWERING ON. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED BUT THE INITIAL REPORTER DID NOT KNOW ANY ADDITIONAL INFORMATION. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272434 ↗
• MalfunctionDec 19, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BULB OF THE HALOGEN LIGHT SOURCE WAS REPLACED AND STOPPED FUNCTIONING. IT WAS NOTED THAT A QUIET BANG OCCURRED WHEN THE DEVICE WAS SWITCHED ON, AND THE REPORTED PHENOMENON OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010897 ↗