EVIS EXERA II XENON LIGHT SOURCE CLV-180Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II XENON LIGHT SOURCE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II xenon light source is used with endoscopes. Of its 137 reports, 136 are malfunctions, mostly describing the light failing to switch on or flickering, the monitor showing only a test pattern, and the brightness not adjusting automatically. There are no deaths and 1 injury among the reports, and reports dropped from 14 in the previous 12 months to 0 in the latest 12 months. 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
- 137
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 04953170216961), received between Aug 25, 2020 and Feb 12, 2025 — classified as 1 injury, 136 malfunctions.
The most frequently reported specific device problem is “No Device Output” (31 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
- No Device Output31
- Electrical /Electronic Property Problem17
- Failure to Power Up11
- No Visual Prompts/Feedback11
- Display or Visual Feedback Problem10
- Output Problem9
- Power Problem8
- Erratic or Intermittent Display7
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- No Consequences Or Impact To Patient13
- No Patient Involvement6
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE MONITOR ONLY DISPLAYS A TEST PATTERN FOR AN IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21366107 ↗MalfunctionDec 13, 2024Erratic or Intermittent Display; Unexpected Shutdown; Erratic or Intermittent Display; Unexpected Shutdown
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FLASHING LIGHTS, AND THE LIGHT SOURCE INTERMITTENTLY TURNS OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925130 ↗MalfunctionDec 11, 2024Optical Problem; Optical Problem
IT WAS REPORTED THAT THE XENON LIGHT BULB DOES NOT LIGHT UP SOMETIMES. THE ISSUE OCCURRED DURING SET UP/INSPECTION FOR USE. THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901663 ↗MalfunctionDec 2, 2024No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20820258 ↗MalfunctionNov 29, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE'S FRONT PANEL FLASHED AND THE LAMP WAS REPLACED WITH A NEW ONE, WHICH DID NOT RESOLVE THE PROBLEM. THE ISSUE OCCURRED DURING THE SERVICE OR MAINTENANCE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20810942 ↗MalfunctionNov 22, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758259 ↗MalfunctionNov 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THE XENON LIGHT SOURCE WAS NOT AUTO ADJUSTING BRIGHTNESS. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, DURING SEDATION, WHILE THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758258 ↗MalfunctionNov 22, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE FRONT PANEL OF THE SUBJECT DEVICE HAD A LIGHTING FAILURE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757075 ↗MalfunctionNov 20, 2024No Device Output; No Device Output
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE LAMP INTENSITY OF THE XENON LIGHT SOURCE WAS INSUFFICIENT, AND THE EMERGENCY LAMP INDICATOR WAS BLINKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738669 ↗MalfunctionNov 19, 2024No Device Output; No Device Output
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE LAMP INTENSITY OF THE XENON LIGHT SOURCE WAS INSUFFICIENT, AND THE EMERGENCY LAMP INDICATOR WAS BLINKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726825 ↗MalfunctionNov 15, 2024Output Problem; Output Problem
NO NEW INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695675 ↗MalfunctionNov 12, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE XENON LIGHT SOURCE HAD BLINKING ON THE EMERGENCY LIGHT. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662890 ↗MalfunctionNov 5, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED, THE XENON LIGHT SOURCE LAMP IS NOT WORKING/NOT RESPONDING. THE ISSUE OCCURRED, DURING PREPARATION FOR USE. FOR AN UNSPECIFIED PROCEDURE. THE FIELD SERVICE ENGINEER FOUND, THE LAMP OF THE FRONT PANEL HAD BLINK ALWAYS. AND THE LAMP BUTTON NOT RESPONDING SOMETIMES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611434 ↗MalfunctionNov 3, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE DID NOT PRODUCE AN IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20595768 ↗MalfunctionSep 25, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THE SUBJECT DEVICE COOLING FAN IS NOT SPINNING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO DELAY AND NO REPORTS OF PATIENT HARM. THE PATIENT WAS NOT UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307129 ↗MalfunctionSep 25, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE XENON LIGHT SOURCE'S FRONT PANEL SWITCHES WERE NOT FUNCTIONING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305385 ↗MalfunctionSep 24, 2024Communication or Transmission Problem; No Visual Prompts/Feedback; Communication or Transmission Problem; No Visual Prompts/Feedback
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE XENON LIGHT SOURCE EXHIBITED E101 AND E102 IGNITION ERRORS, AND THAT THE LAMP WOULD NOT IGNITE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292061 ↗MalfunctionSep 23, 2024No Device Output; No Device Output
IT WAS REPORTED THE SUBJECT DEVICE HAD FRONT PANEL BLINKING/FLASHING/CONTINUING TURNING ON. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20288161 ↗MalfunctionSep 18, 2024Output Problem; Output Problem
IT WAS REPORTED THE XENON LIGHT SOURCE EMERGENCY LAMP INDICATOR AND MAIN LAMP WERE LIT UP AT THE SAME TIME. THE ISSUE OCCURRED DURING MAINTENANCE WITH NO REPORTS OF PATIENT HARM OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246104 ↗MalfunctionSep 17, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THE XENON LIGHT SOURCE LAMP SWITCH IN FRONT PANEL WAS NOT WORKING. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241368 ↗MalfunctionSep 9, 2024No Device Output; No Device Output
FROM THE RESULTS OF DUE DILIGENCE WITH THE USER FACILITY, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE SUGGESTED PHENOMENON: 1. WHAT WAS THE INTENDED PROCEDURE (NAME)? UNKNOWN 2. TYPE OF PROCEDURE (THERAPEUTIC OR DIAGNOSTIC)? DIAGNOSTIC 3. WERE ANY OTHER DEVICES INVOLVED IN THE EVENT? YES A. IF YES, PLEASE LIST THEM AND PROVIDE MODEL/SERIAL NUMBER(S) IF POSSIBLE CV-180 4. WAS THERE ANY DELAY IN THE PROCEDURE IN WHICH THE SUBJECT DEVICE WAS USED? NO A. IF YES, HOW LONG WAS THE DELAY AND WAS THE PATIENT UNDER GENERAL ANESTHESIA? 5. WAS THE INTENDED PROCEDURE COMPLETED? YES 6. WAS THE SAME DEVICE USED TO COMPLETE THE PROCEDURE? NO A. IF NO, WERE THERE OTHER DEVICES USED TO REPLACE THE SUBJECT DEVICE DURING THE PROCEDURE? YES I. IF YES, PLEASE LIST THE DEVICE MODEL(S) AND SERIAL/LOT NUMBER(S) IF KNOWN CV-180 &CLV-180
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20176676 ↗MalfunctionSep 3, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THE BUTTON LIGHTS OF THE LIGHT SOURCE WERE FLASHING WHEN THE SCOPE WAS PLUGGED IN, AND THE BUTTON FUNCTIONS COULD NOT BE USED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. ADDITIONAL DETAILS RELATING TO THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127026 ↗MalfunctionAug 20, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THE LED ON THE FRONT PANEL OF THE LIGHT SOURCE WAS BLINKING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE OF A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008336 ↗MalfunctionAug 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THE LIGHT SOURCE HAD A BLINKING FRONT PANEL. THE ISSUE OCCURRED, DURING PREPARATION FOR USE. FOR A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995951 ↗MalfunctionAug 15, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE XENON LIGHT SOURCE WAS NOT POWERING ON. IT WAS NOT SPECIFIED DURING WHAT TYPE OF DEVICE USAGE THE REPORTED EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995910 ↗
Other Bronchoscope (Flexible Or Rigid) devices
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- 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.
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