HALOGEN LIGHT SOURCE OLYMPUS CLK-4 (UDI 04953170024528)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Quick summary
This Olympus CLK-4 halogen light source provides illumination for endoscopic procedures. The 65 reports mostly describe the unit failing to power on or light its lamp, plus some electrical leakage, casing breakage and front-panel buttons pushed into the device. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 04953170024528), received between Dec 16, 2020 and Apr 30, 2026 — classified as 65 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (20 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.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up20
- Break7
- Electrical /Electronic Property Problem7
- No Device Output7
- Activation Failure4
- No Visual Prompts/Feedback4
- Optical Problem4
- Thermal Decomposition of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient6
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Activation Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE LAMP WAS NOT GETTING ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039160 ↗MalfunctionApr 23, 2026Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE EXHIBITED LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965616 ↗MalfunctionJan 16, 2026Failure to Power Up
IT WAS REPORTED HALOGEN LIGHT SOURCE WAS NOT POWERED ON DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092933 ↗MalfunctionAug 28, 2025Activation Failure; Activation Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PRODUCT EXHIBITED LAMP DOES NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911701 ↗MalfunctionJul 9, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS NOT SWITCHING ON. THE ISSUE WAS FOUND DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462553 ↗MalfunctionJun 25, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE LIGHTSOURCE EXPERIENCED ON/OFF BUTTON ON FRONT PANEL PUSHED INTO DEVICE. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331207 ↗MalfunctionMay 16, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035516 ↗MalfunctionMar 17, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT THE LIGHT SOURCE WAS UNABLE TO LIGHT A LAMP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21623252 ↗MalfunctionSep 18, 2024No Device Output; No Device Output
IT WAS REPORTED THE LIGHT SOURCE¿S LAMP COULD NOT LIGHT UP. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20253090 ↗MalfunctionSep 13, 2024Break; Component Missing; Break; Component Missing
DURING THE DEVICE INSPECTION, IT WAS OBSERVED THAT THE HALOGEN LIGHT SOURCE HAD A DAMAGED FRONT PANEL. ADDITIONALLY, THE MAIN LAMP WAS OF A NON-OLYMPUS TYPE AND THE SPARE LAMP WAS MISSING; BOTH NEED TO BE REPLACED WITH GENUINE OLYMPUS LAMPS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215485 ↗MalfunctionSep 3, 2024Degraded; No Device Output; Degraded; No Device Output
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HALOGEN LIGHT SOURCE EXHIBITED DAMAGE ON A LAMP SOCKET AND ALSO A LAMP DID NOT WORK DUE TO AN EXPIRED SHELF LIFE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130279 ↗MalfunctionAug 28, 2024No Device Output; Failure to Power Up; No Device Output; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE HAD NO POWER. THE ISSUE OCCURRED, DURING MAINTENANCE. AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20089171 ↗MalfunctionAug 21, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LAMP OF THE LIGHT SOURCE DOES NOT LIGHT UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20012019 ↗MalfunctionAug 15, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED, THE LAMP OF THE HALOGEN LIGHT SOURCE BURNT OUT. THE CUSTOMER HAD REPLACED THE LAMP AND THE ISSUE WAS RESOLVED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19989157 ↗MalfunctionAug 5, 2024No Device Output; No Device Output
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LIGHT SOURCE EXHIBITED THE LAMP DOES NOT LIGHT UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19908214 ↗MalfunctionJul 25, 2024Disconnection; Disconnection
DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE EXHIBITED A DISCONNECTION IN THE TRANSFORMER AND IN THE LAMP SOCKET LEADING TO A LOSS OF POWER AND THE LAMP NOT LIGHTING UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19831075 ↗MalfunctionJun 21, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE, WHICH WAS COMPLETED USING A SIMILAR DEVICE, AND WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581125 ↗MalfunctionApr 19, 2024No Device Output; No Device Output
IT WAS REPORTED THE LIGHT SOURCE LAMP WAS FUSE. SUBSEQUENTLY, THE LAMP WAS REPLACED WITH A NEW LAMP AND THE ISSUE WAS RESOLVED. THE ISSUE OCCURRED DURING A ROUTINE CHECK INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19144055 ↗MalfunctionApr 8, 2024Component Missing; Component Missing
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE SPARE LAMP WAS MISSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059232 ↗MalfunctionFeb 26, 2024Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE LAMP WIRE WAS WORN AND THE POWER SUPPLY VOLTAGE WAS UNSTABLE. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON A BRONCHOSCOPE DIAGNOSTIC PROCEDURE. THE FACILITY COMPLETED THIS PROCEDURE USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778105 ↗MalfunctionFeb 26, 2024Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE LAMP WIRE WAS WORN AND THE POWER SUPPLY VOLTAGE WAS UNSTABLE. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON A BRONCHOSCOPE DIAGNOSTIC PROCEDURE. THE FACILITY COMPLETED THIS PROCEDURE USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778013 ↗MalfunctionFeb 26, 2024Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE LAMP WIRE WAS WORN AND THE POWER SUPPLY VOLTAGE WAS UNSTABLE. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON A BRONCHOSCOPE DIAGNOSTIC PROCEDURE. THE FACILITY COMPLETED THIS PROCEDURE USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778007 ↗MalfunctionFeb 26, 2024Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE LAMP WIRE WAS WORN AND THE POWER SUPPLY VOLTAGE WAS UNSTABLE. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON A BRONCHOSCOPE DIAGNOSTIC PROCEDURE. THE FACILITY COMPLETED THIS PROCEDURE USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777995 ↗MalfunctionFeb 22, 2024Crack; Crack
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE POWER SWITCH ON THE LIGHT SOURCE WAS CRACKED. THERE WAS NO REPORTS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18758719 ↗MalfunctionNov 14, 2023Output Problem; Output Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE HAD NO CURRENT COMING FROM THE BOARD. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18132848 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.