VISERA XENON LIGHT SOURCERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of VISERA XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2020 and Apr 14, 2026 — classified as 107 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VISERA XENON LIGHT SOURCE problems
Device problems
- Electrical /Electronic Property Problem32
- Failure to Power Up14
- No Visual Prompts/Feedback9
- Optical Problem7
- Output Problem7
- Display or Visual Feedback Problem6
- No Device Output6
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Consequences Or Impact To Patient16
VISERA XENON LIGHT SOURCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA XENON LIGHT SOURCE CLV-S45Endoscope, accessories, narrow band spectrum73 reports
- VISERA XENON LIGHT SOURCE CLV-S45Light Source, Endoscope, Xenon Arc34 reports
Recent VISERA XENON LIGHT SOURCE adverse event reports
The 15 most recent reports across all models, 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 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21108335 ↗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, 2024Signal Artifact/Noise; Poor Quality Image; Signal Artifact/Noise; Poor Quality Image
IT WAS REPORTED THAT NOISE APPEARED IN THE IMAGE OF THE LIGHT SOURCE. THE ISSUE OCCURRED DURING PREPARATION FOR THE DIAGNOSTIC CYSTOSCOPY. THE PROCEDURE 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 19777055 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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