HALOGEN LIGHT SOURCE CLH-SC (UDI 04953170024481)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Quick summary
This Olympus halogen light source, used in nephroscope kits, supplies the light for endoscopic procedures. The 37 reports mostly describe the unit failing to power on or producing no light, often because the halogen bulb burned out. No deaths or injuries were reported. There are no recalls naming 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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04953170024481), received between Jan 12, 2021 and Mar 9, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (10 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 Up10
- No Visual Prompts/Feedback9
- No Device Output4
- Optical Problem2
- Output Problem2
- Power Problem2
- Activation Failure1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE PRESENTED AN ISSUE IN WHICH THE BULBS FREQUENTLY BURNED OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543330 ↗MalfunctionFeb 26, 2026Optical Problem
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE EXHIBITED A MALFUNCTION IN WHICH THE LIGHT SOURCE WAS BURNING OUT THE BULBS. THE ISSUE WAS DETECTED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461541 ↗MalfunctionDec 24, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE LIGHT SOURCE WAS NOT WORKING DUE TO A BURNED-OUT HALOGEN BULB. THE ISSUE WAS IDENTIFIED DURING REPROCESSING, AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887791 ↗MalfunctionSep 2, 2025Failure to Power Up; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939408 ↗MalfunctionMay 21, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE SUBJECT DEVICE DOESN'T TURN ON. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060938 ↗MalfunctionApr 29, 2025No Device Output; No Device Output
IT WAS REPORTED THE SUBJECT DEVICE HAD NO LIGHT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925334 ↗MalfunctionJan 6, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD A CERAMIC PLUG BURNED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21085219 ↗MalfunctionJan 2, 2025Activation Failure; Activation Failure
IT WAS REPORTED THE LIGHT ON THE LIGHT SOURCE DID NOT TURN ON. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21061300 ↗MalfunctionDec 10, 2024Thermal Decomposition of Device; No Visual Prompts/Feedback; Thermal Decomposition of Device; No Visual Prompts/Feedback
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20896201 ↗MalfunctionOct 19, 2024Loss of Power; Loss of Power
IT WAS REPORTED THE HALOGEN LIGHT SOURCE LAMP WAS BURNT OUT. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20488875 ↗MalfunctionOct 11, 2024No Device Output; No Device Output
IT WAS REPORTED THE LIGHT SOURCE LAMP DID NOT LIGHT UP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433310 ↗MalfunctionOct 7, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED, THE LIGHT SOURCE EXPERIENCED THE MAIN LAMP DID NOT IGNITE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383066 ↗MalfunctionOct 1, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE WAS LAMP NOT WORKING AND WHEN IT HEATS UP THE SYSTEM SHUTS DOWN. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20348854 ↗MalfunctionSep 30, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE LIGHT SOURCE POWER DOES NOT TURN ON. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333014 ↗MalfunctionJul 22, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED, THE LIGHT SOURCE EXHIBITED LIGHT DOES NOT WORK. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801939 ↗MalfunctionJul 18, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE INTENDED PROCEDURE WAS AN UNSPECIFIED DIAGNOSTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19779749 ↗MalfunctionMay 10, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE DID NOT WORK WHEN CONNECTED TO THE BRONCHOSCOPE AND PRODUCED AN ELECTRIC SMELL. THE ISSUE OCCURRED DURING PREPARATION FOR USE WITH NO REPORTS OF PATIENT HARM OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293745 ↗MalfunctionMay 9, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE ISSUE OCCURRED DURING DIAGNOSTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19279071 ↗MalfunctionApr 5, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE LIGHT SOURCE DOES NOT LIGHT UP. THE ISSUE OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19051499 ↗MalfunctionMar 11, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE LIGHT SOURCE EXHIBITED THAT THE CERAMIC LAMP SOCKET UNIT WAS TOO LOOSE WHEN CONNECTED TO HALOGEN LAMP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18881929 ↗MalfunctionFeb 22, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE ISSUE OCCURRED DURING INSPECTION FOR USE PRIOR TO A DIAGNOSTIC UNSPECIFIED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18763221 ↗MalfunctionDec 26, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS NO COLLATION LIGHT OUTPUT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18392367 ↗MalfunctionDec 13, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED TO OLYMPUS THAT THE LIGHT SOURCE HAD A LAMP LIGHTING FAILURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319854 ↗MalfunctionDec 11, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE FUSE BLEW AND THE PRODUCT BECAME UNUSABLE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE FUSE WAS REPLACED. THERE WAS NO USE IF IMPLANT EQUIPMENT AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18302484 ↗MalfunctionNov 17, 2023Electrical Shorting; Electrical Shorting
THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HALOGEN LIGHT SOURCE THE LAMP BURNS OUT (PARTIALLY)WHEN THE POWER IS TURNED ON. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159682 ↗
Other Kit, nephroscope devices
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Olympus Medical Systems Corp. · Kit, nephroscope61 reports
- MIP Minimal Invasive PCNL 27840KAKarl Storz GmbH & Co. KG · Kit, nephroscope1 recall3 reports
- Olympus WA33036AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope27 reports
- Olympus A37025AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope4 deaths20 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · Kit, nephroscope9 reports
- n.a. 27290MKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
- n.a. 27290KKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
- PANOVIEW PLUS 8965401Richard Wolf GmbH · Kit, nephroscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.