VISERA XENON LIGHT SOURCE CLV-S45 (UDI 04953170275777)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of VISERA XENON LIGHT SOURCE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Xenon light source (CLV-S45) powers endoscopes. The 73 reports mostly describe electrical problems: units failing to power up, flickering or going out on their own, showing error or warning lights, and one with an oxidized input connector and a spark. All were found during setup or inspection, with no patient involvement; 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
- 73
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04953170275777), received between Sep 30, 2020 and Apr 14, 2026 — classified as 73 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (22 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem22
- Failure to Power Up11
- No Visual Prompts/Feedback8
- Display or Visual Feedback Problem4
- Erratic or Intermittent Display4
- Output Problem4
- Break3
- Energy Output Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- No Consequences Or Impact To Patient12
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Display or Visual Feedback Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874284 ↗MalfunctionMar 24, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD OXIDIZED INPUT CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672523 ↗MalfunctionMar 17, 2026Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616961 ↗MalfunctionDec 31, 2025Loss of Power; Sparking; Loss of Power; Sparking
IT WAS REPORTED THAT THE LIGHT SOURCE HAD TURNED OFF BY ITSELF AND A SPARK WAS OBSERVED. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23937912 ↗MalfunctionNov 6, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487105 ↗MalfunctionOct 17, 2025Erratic or Intermittent Display; Activation Failure; Erratic or Intermittent Display; Activation Failure
IT WAS REPORTED THAT THE MAIN LAMP OF THE XENON LIGHT SOURCE WAS UNABLE TO LIGHT UP AND THE EMERGENCY LAMP WAS ACTIVATED. 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 23324446 ↗MalfunctionJul 30, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667027 ↗MalfunctionMay 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS NOT RESETTING THE LAMP'S WORKING HOURS AND WAS EMITTING CONSTANT LIGHT SIGNALS, MAKING IT IMPOSSIBLE TO CARRY OUT EXAMS. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079517 ↗MalfunctionMar 3, 2025Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE SUBJECT DEVICE TURNS OFF BY ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510273 ↗MalfunctionJan 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE SCREEN OF VISERA XENON LIGHT SOURCE SHOWED HIGH BRIGHTNESS AND REFLECTION. THE ISSUE WAS FOUND DURING SET UP IN THE ROOM/ INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21064176 ↗MalfunctionNov 26, 2024Output Problem; Output Problem
IT WAS REPORTED, THAT THE SUBJECT DEVICE, WHEN POWERED ON, CAUSED ALL THE INDICATORS TO FLASH .AND COULD NOT BE USED (NO LIGHT CAME ON). THE ISSUE OCCURRED, DURING SETUP/INSPECTION FOR USE IN AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789618 ↗MalfunctionNov 21, 2024Image Orientation Incorrect; Image Orientation Incorrect
THE ISSUE WAS FOUND DURING REPROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20744579 ↗MalfunctionAug 28, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THE FRONT PANEL OF THE LIGHT SOURCE WAS FLICKERING. THE ISSUE OCCURRED, DURING REPROCESSING. THERE WERE NO DELAY, INJURY OR DEATH. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20086223 ↗MalfunctionJul 18, 2024Failure to Power Up; No Visual Prompts/Feedback; Failure to Power Up; No Visual Prompts/Feedback
THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT WAS NOT UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19774592 ↗MalfunctionApr 9, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THE XENON LIGHT SOURCE EXPERIENCED AN ISSUE WITH THE LAMP NOT EMITTING LIGHT. THE ISSUE OCCURRED DURING PREPARATION FOR A THERAPEUTIC PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19076264 ↗MalfunctionMar 12, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED, THE XENON LIGHT SOURCE LAMP DID NOT IGNITE. THE ISSUE OCCURRED DURING A ROUTINE INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18890983 ↗MalfunctionJan 26, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT DURING MAINTENANCE FOUND LAMPLIGHTERS OF XENON LIGHT SOURCE DID NOT LIGHT UP, AND PANEL BUTTONS SOMETIMES DID NOT WORK. THERE WAS NO PROCEDURE INVOLVED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592359 ↗MalfunctionDec 1, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED TO OLYMPUS THAT THE XENON LIGHT SOURCE LIGHTS UP AND SPARE LAMP IS DISPLAYED AT THE SAME TIME AND RESETTING THE LAMP COUNTER IS NOT POSSIBLE. THE ISSUE WAS FOUND AT PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18248478 ↗MalfunctionNov 30, 2023Output Problem; Output Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT VISERA XENON LIGHT SOURCE, THE LIGHT SOURCE WAS FOUND THAT IT CANNOT BE USED NORMALLY. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THE PROCEDURE WAS THERAPEUTIC. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18237306 ↗MalfunctionNov 29, 2023Output Problem; Output Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT VISERA XENON LIGHT SOURCE, THE LAMP DID NOT LIGHT. THE ISSUE OCCURRED AN UNKNOWN EVENT. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18228812 ↗MalfunctionNov 22, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED TO OLYMPUS, THE LIGHT SOURCE LIGHT BULB DOES NOT LIGHT UP. THE ISSUE WAS FOUND DURING PREPARATION. THE THERAPEUTIC PROCEDURE PLASMA CUTTING WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18194018 ↗MalfunctionSep 29, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED THAT AFTER REPLACING THE NON-OLYMPUS LAMP, THE LAMP USAGE TIME DOES NOT RESET TO ZERO WHEN THE XENON LAMP LIFE METER RESET SWITCH IS PRESSED. THE REPORTED PROBLEM WAS FOUND DURING MAINTENANCE. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE LAMP COULD NOT BE LIT DUE TO A DEFECTIVE POWER UNIT. THERE WAS NO PROCEDURE INVOLVED AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED. 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 17848112 ↗MalfunctionSep 12, 2023No Device Output; No Device Output
THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA XENON LIGHT SOURCE HAD OCCASIONAL LIGHTING FAILURES. THE EVENT OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC ABDOMINAL SURGERY. THE 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 17729581 ↗MalfunctionSep 7, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA XENON LIGHT SOURCE HAD ITS MAIN LAMP NOT WORKING BUT THE SPARE LAMP WAS. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE BUT WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAYS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17704814 ↗MalfunctionAug 15, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE WILL AIM FOR XENON LIGHT SOURCE OVER-ILLUMINATED, LIGHT CONTROL NO LONGER WORKS. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND IT WAS FOUND THAT THE OUTPUT CONNECTOR IS BROKEN AND CANNOT BE CONNECTED, AND THE POWER CORD HAS FALLEN OFF, 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 17549536 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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