VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,155 adverse event reports that list this exact device (DI 04953170301995), received between Jun 1, 2020 and Sep 29, 2026 — classified as 5 injuries, 1,150 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (189 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,155 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Complete Blockage; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935650 ↗
• MalfunctionSep 24, 2026No Display/Image; Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876571 ↗
• MalfunctionSep 17, 2026Communication or Transmission Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810255 ↗
• MalfunctionSep 17, 2026Activation Failure

  The customer reported changed the Lamp and he said it came on but in that moment he was not sure if it was on and did not had the scope attached and still had the side panel off of the light source during maintenance involving an Olympus Xenon Light Source. There was no patient involvement reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803608 ↗
• MalfunctionSep 14, 2026Poor Quality Image; Overheating of Device

  The customer reported dark image and lamp burn out during unspecified procedure involving an Olympus xenon light source. There were no reports of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752666 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566023 ↗
• MalfunctionSep 1, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235681 ↗
• MalfunctionAug 26, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457074 ↗
• MalfunctionAug 26, 2026Break; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452033 ↗
• MalfunctionAug 14, 2026Failure to Power Up; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253915 ↗
• MalfunctionAug 11, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208230 ↗
• MalfunctionAug 7, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175233 ↗
• MalfunctionJul 29, 2026Installation-Related Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071433 ↗
• MalfunctionJul 22, 2026Break; Output Problem

  THE CUSTOMER REPORTED THAT THE POWER BUTTON WAS BROKEN AND STUCK, PREVENTING THE OLYMPUS XENON LIGHT SOURCE FROM BEING TURNED ON DURING INSPECTION PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25902584 ↗
• MalfunctionJul 15, 2026Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT LAMP USAGE INDICATOR READS 500 HOURS, AND THE SPARE LAMP MAY HAVE DEPLOYED DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. USING THE INSTRUCTION MANUAL AVAILABLE IN ENDOWISE AS A REFERENCE, BIOMED SHANE HALL POWERED ON THE XENON LIGHT SOURCE ALONG WITH THE REMAINING OLYMPUS TOWER COMPONENTS. HE VERIFIED THAT THE LAMP USAGE INDICATOR ON THE XENON LIGHT SOURCE DISPLAYED 500 HOURS. NO ERROR MESSAGES APPEARED ON THE CONNECTED MONITOR, THE SPARE LAMP INDICATOR REMAINED OFF, AND THE LIGHT OUTPUT FROM THE ENDOSCOPE CONNECTED TO THE XENON LIGHT SOURCE WAS ADEQUATE. THE PART NUMBER WAS ALSO PROVIDED AS THE RECOMMENDED REPLACEMENT LAMP. HE INDICATED THAT HE PLANNED TO ORDER IT AT A LATER DATE. THE CUSTOMER INFORMED TAC OF THE EVENT. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25827620 ↗
• MalfunctionJul 8, 2026No Display/Image; Loose or Intermittent Connection

  THE CUSTOMER REPORTED NO IMAGE AND A LOOSE BOTTOM PLUG DURING AN INSPECTION INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748846 ↗
• MalfunctionJun 26, 2026Communication or Transmission Problem; Output Problem

  THE CUSTOMER RETURNED THE XENON LIGHT SOURCE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE REPAIR CENTER TECHNICIAN FOUND THE BAD FAN NOT WORKING AND SCOPE DETECTOR NOT FUNCTIONAL, CAUSE TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636706 ↗
• MalfunctionJun 9, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER REPORTED THE STANDBY ON LIGHT BUTTON WAS NOT FUNCTIONING ON THE LIGHT SOURCE, DURING THERAPEUTIC URETEROSCOPY PROCEDURE WHICH WAS COMPLETED USING A SIMILAR DEVICE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449058 ↗
• MalfunctionJun 3, 2026Poor Quality Image

  THE CUSTOMER REPORTED DARK IMAGE DISPLAYED DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382943 ↗
• MalfunctionMay 31, 2026Optical Problem

  THE CUSTOMER REPORTED THAT THE LAMP WAS DIM AND NEEDED TO BE REPLACED ON AN OLYMPUS XENON LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345185 ↗
• MalfunctionMay 23, 2026No Display/Image; Poor Quality Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264921 ↗
• MalfunctionMay 23, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD SCOPE ERROR CODE (E200). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264504 ↗
• MalfunctionMay 20, 2026Erratic or Intermittent Display; Connection Problem; Mechanics Altered

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD THE FRONT PANEL BLINKING, THE SWITCH AT THE 12:00 POSITION WAS NOT WORKING WHEN IT WAS EXERCISED, THE PLASTIC TAB INSIDE THE SOCKET WAS STICKY AND WAS NOT MOVING FREELY, THE CONNECTION WAS LOOSE, AND WHEN CONNECTING THE UNIVERSAL LIGHT GUIDE ADAPTER, THE CONNECTION DID NOT STAY SECURED AND FELT LOOSE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229502 ↗
• MalfunctionMay 19, 2026Power Problem

  IT WAS REPORTED THE XENON LIGHT SOURCE WAS FLASHING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220029 ↗
• MalfunctionMay 14, 2026Connection Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD NOT FUNCTIONAL SCOPE DETECTOR ON SCOPE SOCKET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171251 ↗