VISERA ELITE II XENON LIGHT SOURCERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of VISERA ELITE II XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2021 and Aug 22, 2025 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (6 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 ELITE II XENON LIGHT SOURCE problems
Device problems
- Electrical /Electronic Property Problem6
- Detachment of Device or Device Component3
- No Device Output3
- Output Problem3
- Display or Visual Feedback Problem2
- No Display/Image2
- Optical Problem2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient1
VISERA ELITE II XENON LIGHT SOURCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IREndoscope, accessories, narrow band spectrum24 reports
- VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IREndoscope, accessories, narrow band spectrum9 reports
Recent VISERA ELITE 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.
MalfunctionAug 22, 2025Circuit Failure; Circuit Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DAMAGED PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877864 ↗MalfunctionMay 2, 2025Intermittent Loss of Power; Intermittent Loss of Power
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954661 ↗MalfunctionAug 15, 2024No Device Output; No Device Output
IT WAS REPORTED THE XENON LIGHT SOURCE HAD THE LIGHTS WORKING HOWEVER THE PANEL BUTTONS WERE FLASHING. THE ISSUE WAS FOUND DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THERE WERE NO DELAYS REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990144 ↗MalfunctionApr 3, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THE XENON LIGHT SOURCE¿S FRONT PANEL FLICKERED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035692 ↗MalfunctionApr 2, 2024Output Problem; Output Problem
IT WAS REPORTED, THE XENON LIGHT SOURCE FRONT PANEL FLICKERS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020295 ↗MalfunctionMar 11, 2024Noise, Audible; Noise, Audible
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED ABNORMAL NOISE DUE TO FRONT PANEL INTERNAL SCREWS ARE DETACHED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18873665 ↗MalfunctionFeb 5, 2024No Device Output; No Device Output
THE COSTUMER REPORTED THAT THERE WAS NO DELAY AND PATIENT WAS NOT UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640521 ↗MalfunctionJan 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE LIGHT SOURCE FRONT PANEL FLICKERED. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443029 ↗MalfunctionDec 13, 2023Output Problem; Output Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE FRONT PANEL OF THE XENON LIGHT SOURCE WAS FLASHING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18322071 ↗MalfunctionNov 3, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE, THE VISERA ELITE II XENON LIGHT SOURCE WHEN TURNED ON, ITS EMERGENCY LAMP WOULD BLINK BUT THE LAMP DOES NOT SWITCH ON. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064458 ↗MalfunctionOct 31, 2023Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE II XENON LIGHT SOURCE HAD A E207 SPARE LAMP ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18041867 ↗MalfunctionOct 31, 2023No Device Output; No Device Output
THE CUSTOMER REPORTED TO OLYMPUS, THE XENON LIGHT SOURCE FRONT PANEL FLICKERED DUE TO THE FIXING SCREW MOTOR ON TURRET WAS DETACHED. THE EVENT WHERE THE ISSUE WAS FOUND IS UNKNOWN. THERE WAS NO DELAY AND THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18041258 ↗MalfunctionJul 17, 2023Power Problem; Power Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE II XENON LIGHT SOURCE HAD THE POWER COMPLETELY CUT OFF WITH THE POWER CABLE FALLING OUT. THE CUSTOMER SUSPECTED THIS WAS DUE TO LOOSENING OF THE PLUG-IN CONNECTOR DUE TO VIBRATION WHEN MOVING THE TROLLEY AND THE PULLING FORCE OVER TIME. THE ISSUE WAS FOUND DURING THE RIGHT PARTIAL LUNG RESECTION AND MEDIASTINAL LYMPH NODE BIOPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED AS THE POWER CORD WAS REINSERTED TO CONTINUE. THE FOLLOWING COMPLAINTS ARE RELATED: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333893 ↗MalfunctionJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, THAT THE VISERA ELITE II XENON LIGHT SOURCE SHOWED ERROR E112. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND DETACHMENT OF THE SCREWS ON THE FILTER TURNTABLE. THERE WAS NO REPORT OF DELAY OR HARM TO A PATIENT OR USER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17249139 ↗MalfunctionJun 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
A CUSTOMER REPORTED THAT DURING INSPECTION BEFORE USE, ERROR CODE E207 (CLV SPARE LAMP ERROR) WAS SHOWN AND THEN "THE ERROR WAS CLOSED" ON THE VISERA ELITE II XENON LIGHT SOURCE. AN UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17211035 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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