XENON LAMPRecalls & 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
- 91
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of XENON LAMP by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2018 and May 25, 2026 — classified as 91 malfunctions.
The most frequently reported specific device problem is “Output Problem” (14 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 XENON LAMP problems
Device problems
- Output Problem14
- Optical Problem12
- No Device Output11
- Communication or Transmission Problem9
- Electrical /Electronic Property Problem8
- No Visual Prompts/Feedback6
- Poor Quality Image5
- Defective Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions83
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient2
XENON LAMP models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XENON LAMP MAJ-1817Colonoscope And Accessories, Flexible/Rigid61 reports
- Xenon Lamp MD-631Endoscopic video imaging system/component, gastroenterology-urology30 reports
Recent XENON LAMP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Optical Problem
IT WAS REPORTED THAT THE LAMP EXHIBITED INSUFFICIENT BRIGHTNESS. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271003 ↗MalfunctionApr 29, 2026Poor Quality Image; Output Problem; Activation Failure
IT WAS REPORTED THAT THE LAMP DISPLAYED A BLURRY AND DARK IMAGE, AND THE BULB DID NOT LIGHT. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035349 ↗MalfunctionFeb 3, 2026Output Problem
IT WAS REPORTED THAT THE XENON LAMP E103 ERROR OCCURRED. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248326 ↗MalfunctionJan 2, 2026Poor Quality Image; Output Problem
IT WAS REPORTED THAT THE XENON LAMP EXPERIENCED A NOISED SCREEN AND A BULB ERROR. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945065 ↗MalfunctionJan 2, 2026Poor Quality Image
IT WAS REPORTED THAT THE XENON LAMP HAD A NOISY SCREEN. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944950 ↗MalfunctionDec 29, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23910826 ↗MalfunctionDec 29, 2025Output below Specifications; Output below Specifications
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908480 ↗MalfunctionDec 23, 2025Poor Quality Image; Poor Quality Image
THE REPORTED DARK IMAGE HAPPENED DURING UNSPECIFIED DIAGNOSTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878842 ↗MalfunctionNov 11, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE LAMP EXHIBITED INSUFFICIENT BRIGHTNESS AFTER ABOUT A WEEK OF USE AND OCCASIONALLY FAILED TO LIGHT UP NORMALLY, RESULTING IN A STARTUP ERROR (E102). THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE BEFORE SEDATION OF A DIAGNOSTIC GENERAL MEDICAL TREATMENT PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526769 ↗MalfunctionNov 11, 2025Output Problem; Output Problem
IT WAS REPORTED THE LAMP EXHIBITED AN ERROR AND THE BRIGHTNESS WAS INSUFFICIENT; IT WAS UNABLE TO LIGHT UP OCCASIONALLY. THE ISSUE WAS FOUND DURING SEDATION FOR A DIAGNOSTIC GENERAL EXAMINATION PROCEDURE AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526713 ↗MalfunctionNov 11, 2025No Device Output; No Device Output
IT WAS REPORTED THAT THE LAMP HAD AN ERROR, THE BRIGHTNESS WAS INSUFFICIENT. THE ISSUE WAS FOUND DURING A DIAGNOSTIC GENERAL EXAMINATION 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 23526642 ↗MalfunctionNov 11, 2025No Device Output; Output Problem; No Device Output; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525902 ↗MalfunctionNov 11, 2025Display or Visual Feedback Problem; Activation Failure; Display or Visual Feedback Problem; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525838 ↗MalfunctionOct 28, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE XENON LAMP WENT DARK AFTER ABOUT 50 HOURS OF USE. THE EVENT OCCURRED DURING SEDATION FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408314 ↗MalfunctionSep 30, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23184510 ↗
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.
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