EVIS EXERA III XENON LIGHT SOURCERecalls & 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
- 6,694
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls
- 0
We found 2 models of EVIS EXERA III XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 6,694 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2018 and Sep 30, 2026 — classified as 54 injuries, 6,640 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (2,583 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 EVIS EXERA III XENON LIGHT SOURCE problems
Device problems
- Communication or Transmission Problem2,583
- No Display/Image743
- Output Problem397
- Electrical /Electronic Property Problem381
- Poor Quality Image278
- Failure to Power Up267
- No Device Output234
- Display or Visual Feedback Problem226
Patient problems
- No Clinical Signs, Symptoms or Conditions6,470
- No Consequences Or Impact To Patient129
- No Patient Involvement80
- Perforation6
- No Known Impact Or Consequence To Patient5
- Abdominal Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information3
EVIS EXERA III XENON LIGHT SOURCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Colonoscope And Accessories, Flexible/Rigid77 reports
Recent EVIS EXERA III 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.
MalfunctionSep 30, 2026Corroded; Mechanical Problem
The customer returned the Xenon Light Source with no reported complaint. During the evaluation of the device, a screw was stuck on the rear panel, and corrosion inside the socket tubing was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941799 ↗MalfunctionSep 29, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941404 ↗MalfunctionSep 29, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941146 ↗MalfunctionSep 29, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937687 ↗MalfunctionSep 29, 2026No Display/Image; Communication or Transmission Problem
It was reported that during a diagnostic colonoscopy, the light source displayed a B30 error code with multiple scopes. The device was turned off and back on; however, the issue persisted, with the image described as fuzzy and black. There were no reports of further patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937178 ↗MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934820 ↗MalfunctionSep 28, 2026Activation Problem
The customer reported the Xenon light source had a separate issue. During the initial evaluation of the device it was observed, blinking front panel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923458 ↗MalfunctionSep 28, 2026Optical Problem
The customer reported the xenon light source had dim light on the monitor during an unspecified unspecified procedure, which was completed with the same set of equipment. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915188 ↗MalfunctionSep 25, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905831 ↗MalfunctionSep 25, 2026Connection Problem
The customer returned the xenon light source to the service center for a separate issue. During the device analysis, the service repair technician indicates that device had scope detector not functional on scope socket. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903132 ↗MalfunctionSep 25, 2026Erratic or Intermittent Display
The customer reported intermittent issues involving an Olympus xenon light source. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899464 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported scope communication error during an inspection for use involving an Olympus xenon light source. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896455 ↗MalfunctionSep 25, 2026Communication or Transmission Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892541 ↗MalfunctionSep 25, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892485 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892428 ↗
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 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
- 4K CAMERA HEAD3 models · 4,926 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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