VISERA Pro XENON LIGHT SOURCE OLYMPUS CLV-S40Pro (UDI 04953170228940)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of VISERA Pro XENON LIGHT SOURCE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus VISERA Pro xenon light source, which powers endoscopes, has 269 reports, with no deaths and 1 injury. Some describe electrical faults, no light output, or the unit failing to power up. Several describe problems found during checks before use, with no patient involved. Reports fell to 12 in the last 12 months from 25 the year before.
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
- 269
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 04953170228940), received between Aug 26, 2019 and Sep 17, 2026 — classified as 1 injury, 268 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (59 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 Problem59
- No Device Output45
- Failure to Power Up36
- No Visual Prompts/Feedback30
- Display or Visual Feedback Problem13
- Erratic or Intermittent Display13
- Output Problem12
- Thermal Decomposition of Device12
Patient problems
- No Clinical Signs, Symptoms or Conditions253
- No Consequences Or Impact To Patient14
- No Code Available2
Recent adverse event reports
The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionAug 6, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726841 ↗MalfunctionAug 4, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BLINKING FRONT PANEL, DURING SET-UP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710579 ↗MalfunctionJul 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394641 ↗MalfunctionJun 18, 2025No Device Output; No Device Output
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FRONT PANEL FLICKERED. THE ISSUE WAS FOUND DURING LAB OR DEMONSTRATION. THE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287846 ↗MalfunctionJun 12, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD PANEL FLICKERING. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22197722 ↗MalfunctionMay 23, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD LIGHT SOURCE BULB IN THE CAMERA SYSTEM WHICH WAS NOT WORKING. THE ISSUE WAS FOUND DURING LAPAROSCOPIC PREOPERATIVE PREPARATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081035 ↗MalfunctionApr 30, 2025Erratic or Intermittent Display; Electrical /Electronic Property Problem; Erratic or Intermittent Display; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936634 ↗MalfunctionMar 27, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FRONT PANEL BLINKING. THE ISSUE WAS FOUND DURING SET UP OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21711680 ↗MalfunctionMar 27, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705416 ↗MalfunctionMar 26, 2025Erratic or Intermittent Display; Unexpected Shutdown; Erratic or Intermittent Display; Unexpected Shutdown
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21704427 ↗MalfunctionMar 19, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED THE FRONT PANEL MALFUNCTION, CONTROL PANEL FLASHING, ABNORMAL LIGHT INTENSITY, THE ISSUE OCCURRED DURING INSPECTION FOR USE BEFORE THE PATIENT ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642508 ↗
Other Endoscope, accessories, narrow band spectrum devices
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- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
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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