VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400 (UDI 04953170374579)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of VISERA 4K UHD XENON LIGHT SOURCE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus VISERA 4K xenon light source provides light for endoscopes used in bronchoscopy. Several reports describe the unit giving no output or failing to power up, and some describe connection faults. A few describe patient burns. The 156 reports include no deaths and 6 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
- 157
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 04953170374579), received between Apr 24, 2020 and Sep 28, 2026 — classified as 6 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (15 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 Problem15
- No Device Output15
- Connection Problem14
- Communication or Transmission Problem13
- Failure to Power Up12
- Output Problem10
- Break6
- Display or Visual Feedback Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- No Consequences Or Impact To Patient5
- Burn(s)3
- Partial thickness (Second Degree) Burn2
- Arrhythmia1
- Blister1
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924030 ↗MalfunctionSep 21, 2026Loose or Intermittent Connection; Poor Quality Image
The customer reported camera was dark and the prong pops out with an Olympus xenon light source. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837407 ↗MalfunctionSep 8, 2026No Device Output; Activation Failure; Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679302 ↗MalfunctionSep 2, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569751 ↗MalfunctionMay 23, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD A LOOSE INTERNAL PISTON. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263734 ↗MalfunctionMay 5, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE WAS NOT BRIGHT. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDO NASAL PROCEDURE THAT WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083268 ↗MalfunctionApr 28, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED FRONT PANEL LIGHTS BLINKING AND IRIS UNIT WORKING INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016819 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED LEVEL FOR HIGH INTENSITY SWITCH IS BROKEN OR DAMAGE, FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983633 ↗MalfunctionApr 16, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD DAMAGED FAN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24898649 ↗MalfunctionApr 13, 2026Optical Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE DISPLAYED INSUFFICIENT OUTPUT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858834 ↗MalfunctionMar 16, 2026Naturally Worn; Optical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD A WORN-OUT SOCKET SLIDER SWITCH AND A FAILURE OF THE HIGH-INTENSITY MODE SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24610249 ↗MalfunctionFeb 24, 2026Power Problem; Key or Button Unresponsive/not Working
IT WAS REPORTED THE XENON LIGHT SOURCE HAD A STUCK AND COMPLETELY DEPRESSED POWER BUTTON AND WILL NOT POWER ON. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436951 ↗MalfunctionJan 13, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24055568 ↗MalfunctionJan 2, 2026No Device Output
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944877 ↗MalfunctionDec 12, 2025Connection Problem; Connection Problem
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE IMAGE WAS INTERMITTENTLY MISSING FROM THE MONITOR; DETECTED A FAULT IN THE HEAD; IMAGE WAS LOST ON THE MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23793486 ↗MalfunctionDec 12, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE XENON LIGHT SOURCE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788852 ↗MalfunctionDec 3, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE, LIGHT IS NOT COMING ON ANYMORE FOR THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706757 ↗MalfunctionNov 14, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23559672 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526251 ↗MalfunctionNov 10, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THE XENON LIGHT SOURCE HAD ITS AUTOCLAVE CABLE CAUSED A MINOR BURN, DURING SERVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513479 ↗MalfunctionOct 30, 2025Poor Quality Image; Material Integrity Problem; Poor Quality Image; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426625 ↗MalfunctionOct 24, 2025Activation Problem; Activation Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT A NON-OLYMPUS LAMP WAS USED IN THE SUBJECT DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380517 ↗MalfunctionOct 15, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290546 ↗MalfunctionSep 10, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017342 ↗MalfunctionSep 8, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991922 ↗
Other BRONCHOSCOPE (FLEXIBLE OR RIGID) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 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.
How reports and recalls are matched · Editorial policy · Report an error on this page