HALOGEN LIGHT SOURCE CLH-250 (UDI 04953170024429)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04953170024429), received between Sep 16, 2020 and May 25, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (11 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Overheating of Device

  THE CUSTOMER RETURNED THE HALOGEN LIGHT SOURCE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BURNT-OUT BULB WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO HIGH-ENERGY INSTRUMENTS (SUCH AS HIGH-FREQUENCY DEVICES) WERE USED WITHOUT MAINTAINING SUFFICIENT DISTANCE FROM THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271688 ↗
• MalfunctionMay 7, 2026Naturally Worn

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE HALOGEN LIGHT SOURCE FAILED TO ILLUMINATE, WHICH WAS ATTRIBUTED TO A WORN LAMP SOCKET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116682 ↗
• MalfunctionMar 9, 2026Activation Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE HAD FAILURE TO START UP DUE TO THE TEMPERATURE SENSOR MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543535 ↗
• MalfunctionDec 18, 2025Failure to Power Up; Activation Failure; Failure to Power Up; Activation Failure

  IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE HAD NO LIGHTING AND THE CONSOLE DID NOT POWER ON. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838826 ↗
• MalfunctionSep 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE SUBJECT DEVICE EXPERIENCED HALOGEN LAMP BURNT. THE ISSUE OCCURRED DURING SET UP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075738 ↗
• MalfunctionAug 6, 2025Explosion; Explosion

  IT WAS REPORTED THAT THE LIGHT SOURCE OF THE SUBJECT DEVICE EXPLODED DURING SETUP IN ROOM, INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726211 ↗
• MalfunctionJan 30, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  NO OTHER UPDATED INFORMATION FROM THE "CUSTOMER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280524 ↗
• MalfunctionDec 5, 2024Optical Problem; Optical Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857225 ↗
• MalfunctionJul 3, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT WHEN THE LIGHT SOURCE WAS CONNECTED TO THE CAMERA, THE LIGHT SOURCE SUDDENLY DID NOT LIGHT UP. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPIC STENT REMOVAL SURGERY. THERE WAS NO ALTERNATIVE LIGHT SOURCE, THEREFORE THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WHICH WAS REPORTED TO POTENTIALLY PROLONG SURGERY TIME. HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670717 ↗
• MalfunctionJun 24, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT THE LAMP FROM THE LIGHT SOURCE DOES NOT LIGHT EVEN WHEN NEW. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593453 ↗
• MalfunctionApr 17, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT WHEN DOING INSPECTION FOR THE PATIENT, NO IMAGE WAS FOUND USING THE HALOGEN LIGHT SOURCE. THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126920 ↗
• MalfunctionMar 21, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954044 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT SOURCE WAS DAMAGED. THE ISSUE OCCURRED AT PREPARATION FOR USE FOR A LAPAROSCOPIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME TYPE OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651995 ↗
• MalfunctionDec 18, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE LAMP DID NOT LIGHT. THE PROCEDURE WAS THERAPEUTIC AND WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348386 ↗
• MalfunctionNov 28, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED TO OLYMPUS, DURING AN INSPECTION FOR A PATIENT, THE HALOGEN LIGHT SOURCE POWER SWITCH COULD NOT BE TURNED ON. THE SUBJECT DEVICE WAS REPLACED, AND THE INSPECTION FINISHED. THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215337 ↗
• MalfunctionNov 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE LIGHT SOURCE HAD ABNORMAL NOISE INSIDE. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WAS NO REPORT ON DELAY, PATIENT HARM OR INJURY ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION FOUND THE SCREW INSIDE THE DEVICE WAS DETACHED AS A REPORTABLE MALFUNCTION. 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 18179308 ↗
• MalfunctionNov 7, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE, STATING THAT THEY FOUND HALOGEN LAMP OF (CLH-250) THAT DOESN¿T WORK, AND THE FAN MAKES A LOUD NOISE. THE ISSUE OCCURRED DURING THE PREPARATION FOR USE. THE PROCEDURE WAS DIAGNOSTIC. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084604 ↗
• MalfunctionOct 21, 2023Failure to Power Up; Defective Component; Failure to Power Up; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THE HALOGEN LIGHT SOURCE DOES NOT START. THERE WAS NO PROCEDURE INVOLVED AND NO REPORTS OF PATIENT OR USER HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, ANOTHER REPORTABLE MALFUNCTION WAS FOUND: FAN FAILURE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE BOTH REPORTABLE MALFUNCTIONS: ONE REPORTED BY THE CUSTOMER AND THE OTHER FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982169 ↗
• MalfunctionSep 29, 2023Electromagnetic Interference; Electromagnetic Interference

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE WAS NOT FUNCTIONING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND IT WAS FOUND THAT WHEN THE SWITCH WAS TURNED ON, THE FAN DID NOT TURN, AND THE LAMP DID NOT LIGHT UP. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842427 ↗
• MalfunctionJul 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE SHELL WAS SEVERELY DEFORMED, AND THE REFLECTOR WAS DETACHED. THERE WAS NO PROCEDURE INVOLVEMENT OR DELAY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302442 ↗
• MalfunctionJun 1, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE HAD A BURNING SMELL. UPON TROUBLESHOOTING, THE CUSTOMER NOTICED A BURN MARK ON THE INTERNAL HARNESS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. DURING EVALUATION, A POWER SUPPLY FAILURE WAS FOUND. 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 17040416 ↗
• MalfunctionApr 24, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE SWITCH ON HIS OLYMPUS HALOGEN LIGHT SOURCE WAS GETTING JAMMED IN THE DEPRESSED SETTING. ACCORDING TO THE INITIAL REPORTER, THIS EVENT TOOK PLACE DURING ROUTINE MAINTENANCE AND HAD NO PATIENT INVOLVEMENT. THE CUSTOMER OPTED TO SEND THE DEVICE TO A 3RD PARTY REPAIR FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795109 ↗
• MalfunctionApr 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BULB ON THE HALOGEN LIGHT SOURCE FREQUENTLY BURNS, THE BULB HOLDER AND CIRCUIT BOARD WERE DEFECTIVE. THE DEVICE WAS INSPECTED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739361 ↗
• MalfunctionDec 29, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, LAMP NEED TO BE REPLACED AS IT HAS REACHED TO ITS SERVICE LIFE ON THE HALOGEN LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075940 ↗
• MalfunctionDec 28, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE, THE LAMP WENT OUT ON THE 4 HALOGEN LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064220 ↗