EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190 (UDI 04953170298868)Recalls & reported problems
Olympus Medical Systems Corp. · CLV-190 EVIS EXERA III LIGHT SOURCE · 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 light source is a xenon lighting unit used with Olympus scopes. Of its 6,545 reports, none are deaths and 54 are injuries. Many describe communication problems with the scope, blank images, output problems and failures to power up. Recent service reports mention corrosion inside air tubing. 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
- 6,617
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6,617 adverse event reports that list this exact device (DI 04953170298868), received between Jun 21, 2018 and Sep 30, 2026 — classified as 54 injuries, 6,563 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (2,546 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 Problem2,546
- No Display/Image731
- Output Problem388
- Electrical /Electronic Property Problem380
- Poor Quality Image274
- Failure to Power Up267
- No Device Output232
- Display or Visual Feedback Problem224
Patient problems
- No Clinical Signs, Symptoms or Conditions6,393
- 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
Recent adverse event reports
The 25 most recent of 6,617 reports, 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 ↗MalfunctionSep 24, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892272 ↗MalfunctionSep 24, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891126 ↗MalfunctionSep 24, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890652 ↗MalfunctionSep 24, 2026No Display/Image
The customer reported that not transmitting pictures or video involving an Olympus xenon light source. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886313 ↗MalfunctionSep 24, 2026Key or Button Unresponsive/not Working
The customer reported the xenon light source unable to take a picture during Inspection for use. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885338 ↗MalfunctionSep 23, 2026Blocked Connection
The customer reported that the device was not connecting with the scopes during inspection for use involving an Olympus light source. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863510 ↗MalfunctionSep 22, 2026Corroded; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861073 ↗MalfunctionSep 22, 2026Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860852 ↗MalfunctionSep 22, 2026Communication or Transmission Problem
The customer reported a B30 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 50859829 ↗MalfunctionSep 22, 2026Leak/Splash
The customer reported leaks when the scope is attached, 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 50855431 ↗
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-0063-2026 · Sep 11, 2025 · Open, ClassifiedEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
- 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-0050-2026 · Sep 11, 2025 · Open, ClassifiedBRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
- 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-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-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-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-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-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-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 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
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 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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