EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190 (REF N3643342)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III XENON LIGHT SOURCE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA III xenon light source powers endoscopes so doctors can see inside the body. The 74 reports mostly describe the scope refusing to communicate with the light source, along with blank, flickering, dim, or poor-quality images. No deaths or injuries were reported, and 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
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170465970), received between Jan 28, 2025 and Sep 23, 2026 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (37 reports).
18 other recalls cover devices cleared under the same FDA submission (K121959, K131780); they may or may not involve this specific model.
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
- Communication or Transmission Problem37
- No Display/Image12
- Output Problem9
- Connection Problem4
- Poor Quality Image4
- Erratic or Intermittent Display3
- Optical Problem3
- Display or Visual Feedback Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions77
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872824 ↗MalfunctionSep 10, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718012 ↗MalfunctionSep 9, 2026No Display/Image; Connection Problem
The customer reported that a black screen with no image, a rainbow pattern displayed and the system did not detect the connected scope during inspection for use involving an Olympus Xenon Light Source. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694932 ↗MalfunctionAug 5, 2026Connection Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147140 ↗MalfunctionJul 31, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101423 ↗MalfunctionJul 28, 2026Communication or Transmission Problem
The customer reported scope communication error(B30) during inspection prior to use involving an Olympus xenon light source. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059682 ↗MalfunctionJul 28, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054205 ↗MalfunctionJul 27, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025311 ↗MalfunctionJul 7, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED B30 SCOPE COMMUNICATION ERROR DURING INSPECTION FOR USE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25735799 ↗MalfunctionJun 26, 2026Poor Quality Image
CUSTOMER REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE XENON LIGHT SOURCE WAS MALFUNCTIONING AND CAUSING THE ULTRASOUND IMAGE TO NARROW DOWN ON BOTH THE LEFT AND RIGHT SIDE AND THE EDGES WERE BLACK. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644349 ↗MalfunctionJun 6, 2026Poor Quality Image; Activation Failure
THE CUSTOMER REPORTED LIGHT DIM AND SPARE LIGHT ILLUMINATED DURING A LAB INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25419586 ↗MalfunctionJun 1, 2026No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD IMAGE BLACKOUT. THE ISSUE WAS FOUND DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349535 ↗MalfunctionMay 11, 2026No Display/Image
IT WAS REPORTED THAT XENON LIGHT SOURCE HAD NO IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136294 ↗MalfunctionApr 29, 2026Activation Problem
IT WAS REPORTED THAT THE LIGHT SOURCE UNIT WAS BLINKING. THE ISSUE WAS FOUND DURING INSPECTION BEFORE USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032423 ↗MalfunctionApr 27, 2026No Display/Image
IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED LOSS OF IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001404 ↗MalfunctionApr 25, 2026No Display/Image; Mechanical Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO ENDOSCOPIC IMAGE, THE IMAGE WENT BLACK AND SLIDE SWITCH MALFUNCTION. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24991994 ↗MalfunctionApr 24, 2026Output Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE DISPLAYED AN ERROR MESSAGE E101. THE ISSUE WAS IDENTIFIED DURING AN INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982362 ↗MalfunctionApr 23, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE XENON LIGHT SOURCE LOST PICTURE WHEN SCOPE WAS MOVED. THE ISSUE WAS IDENTIFIED DURING A THERAPEUTIC COLONOSCOPY PROCEDURE. 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 24968298 ↗MalfunctionApr 22, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD B30 SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955224 ↗MalfunctionApr 21, 2026Optical Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD LOSING LIGHT HALFWAY THROUGH THE PROCEDURE; IT WAS BEING REDUCED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939502 ↗MalfunctionApr 15, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED A SCOPE COMMUNICATION ERROR (B30). THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889308 ↗MalfunctionApr 13, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866916 ↗MalfunctionApr 7, 2026Output Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD AN ERROR CODE E101 DURING SET-UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800259 ↗MalfunctionMar 23, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670286 ↗MalfunctionMar 19, 2026Output Problem
IT WAS REPORTED THE FRONT PANEL LIGHT-EMITTING DIODES OF THE XENON LIGHT SOURCE WERE FLASHING. 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 24643001 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121959, K131780. One submission often covers many models, so check the product and lot details in each record.
- Z-0050-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- Z-0049-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
- Z-0060-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-Q170
- Z-0063-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
- Z-0053-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
- Z-1210-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0192-2024 · Oct 12, 2023 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
- Z-0327-2024 · Sep 25, 2023 · Open, ClassifiedBronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190
- Z-0341-2024 · Sep 25, 2023 · Open, ClassifiedColonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
- Z-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil
…and 3 more.
Other Colonoscope And Accessories, Flexible/Rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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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