VISERA Pro 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
- 427
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of VISERA Pro XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 427 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2019 and Sep 23, 2026 — classified as 1 injury, 426 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (101 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 Pro XENON LIGHT SOURCE problems
Device problems
- Electrical /Electronic Property Problem101
- No Device Output62
- Failure to Power Up52
- No Visual Prompts/Feedback32
- Display or Visual Feedback Problem24
- Erratic or Intermittent Display19
- Power Problem19
- Output Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions407
- No Consequences Or Impact To Patient19
- No Code Available2
VISERA Pro XENON LIGHT SOURCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA Pro XENON LIGHT SOURCE OLYMPUS CLV-S40ProEndoscope, accessories, narrow band spectrum269 reports
- VISERA Pro XENON LIGHT SOURCE OLYMPUS CLV-S40ProEndoscope, accessories, narrow band spectrum158 reports
Recent VISERA Pro 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 23, 2026Activation Failure
The customer reported Main lamp does not ignite during inspection for use involving an Olympus xenon light source. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872468 ↗MalfunctionSep 17, 2026Erratic or Intermittent Display; Power Problem; Key or Button Unresponsive/not Working
The customer reported switch malfunction and panel flickering during inspection for use involving an Olympus xenon light source. During the initial evaluation of the returned device, the power could not be turned off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802826 ↗MalfunctionSep 2, 2026Mechanical Problem; Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565887 ↗MalfunctionAug 31, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531569 ↗MalfunctionMay 21, 2026Circuit Failure
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE XENON LIGHT SOURCE EXHIBITED FRONT PANEL BLINKING, MAIN BOARD FAILURE, DIMMING OF THE EMERGENCY LIGHT, AND EMERGENCY LIGHT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25239987 ↗MalfunctionFeb 11, 2026Activation Failure
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD EXPERIENCED LAMP IGNITER MALFUNCTIONS. THE ISSUE WAS FOUND DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319388 ↗MalfunctionJan 28, 2026Output Problem
IT WAS REPORTED THE LIGHT SOURCE'S LIGHT DID NOT LIGHT UP DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199766 ↗MalfunctionJan 16, 2026Activation Failure
IT WAS REPORTED THE LIGHT SOURCE WAS NOT WORKING AND XENON LAMP WAS NOT SWITCHING ON DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092947 ↗MalfunctionJan 14, 2026Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24070930 ↗MalfunctionJan 8, 2026No Visual Prompts/Feedback
IT WAS REPORTED THAT THE XENON LIGHT SOURCE FAILED TO IGNITE THE LAMP. 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 24006219 ↗MalfunctionDec 30, 2025No Device Output; No Device Output
IT WAS REPORTED THE PANEL OF THE LIGHT SOURCE WAS FLICKERING. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924392 ↗MalfunctionDec 23, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881323 ↗MalfunctionNov 11, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO IMAGE. THE ISSUE WAS FOUND DURING SET UP FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523496 ↗MalfunctionSep 17, 2025No Device Output; Failure to Power Up; No Device Output; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073553 ↗MalfunctionAug 12, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783023 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page