EVIS EXERA II 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
- 588
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 2 models of EVIS EXERA II XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 588 adverse event reports in the FDA's MAUDE database, received between May 8, 2019 and Sep 25, 2026 — classified as 6 injuries, 582 malfunctions.
The most frequently reported specific device problem is “No Device Output” (89 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 EVIS EXERA II XENON LIGHT SOURCE problems
Device problems
- No Device Output89
- Failure to Power Up83
- Electrical /Electronic Property Problem81
- Display or Visual Feedback Problem49
- Power Problem42
- Output Problem33
- No Visual Prompts/Feedback29
- No Display/Image24
Patient problems
- No Clinical Signs, Symptoms or Conditions534
- No Consequences Or Impact To Patient30
- No Patient Involvement26
- Perforation2
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
- Shock1
- Unspecified Respiratory Problem1
EVIS EXERA II XENON LIGHT SOURCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180Endoscope, accessories, narrow band spectrum451 reports
- EVIS EXERA II XENON LIGHT SOURCE CLV-180Bronchoscope (Flexible Or Rigid)137 reports
Recent EVIS EXERA II 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.
MalfunctionSep 25, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892550 ↗MalfunctionSep 17, 2026No Display/Image
The customer reported no image during an inspection for use involving an Olympus xenon light source. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805891 ↗MalfunctionJul 9, 2026Activation Failure
THE CUSTOMER REPORTED THAT IT IS BLINKING ALL OF THE LIGHTS ARE BLINKING INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25761774 ↗MalfunctionMay 13, 2026No Device Output
THE CUSTOMER REPORTED BLINKING LIGHTS DURING SET-UP INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THE CUSTOMER SUSPECTED THE PROBABLE CAUSE OF THE BLINKING LIGHTS WAS DUE TO SWITCH IN 12 O¿CLOCK POSITION THAT MAYBE ENGAGING WITHOUT THE SCOPE SEATED PROPERLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162273 ↗MalfunctionMay 7, 2026Poor Quality Image; No Device Output
IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED SPARE LAMP WAS NOT ON AND LAMP WAS VERY DIM. THE ISSUE WAS FOUND DURING GASTRODUODENOSCOPY DIAGNOSTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112885 ↗MalfunctionApr 20, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBIT BLINKING FRONT PANEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933646 ↗MalfunctionApr 2, 2026Display or Visual Feedback Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD POOR LIGHT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24763286 ↗MalfunctionMar 25, 2026No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE WAS UNABLE TO OBTAIN A PICTURE ON THE MONITOR DURING A CYSTOSCOPY DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688294 ↗MalfunctionMar 18, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD INTERMITTENT IMAGE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635015 ↗MalfunctionMar 11, 2026No Device Output
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD STROBING LIGHT. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24569382 ↗MalfunctionMar 5, 2026Output Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD FLASHING BULB UNTIL IT WENT OUT AND THE EMERGENCY BULB CAME ON. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518702 ↗MalfunctionFeb 24, 2026No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO IMAGE DURING SEDATION OF AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429476 ↗MalfunctionFeb 18, 2026Power Problem
IT WAS REPORTED THE LIGHT SOURCE HAD NO POWER ON IT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384584 ↗MalfunctionFeb 11, 2026Failure to Power Up
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO POWER. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314009 ↗MalfunctionFeb 5, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD THE FRONT PANEL FLASHING ON ALL FUNCTIONS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273477 ↗
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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