EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 04953170215544), received between May 8, 2019 and Sep 25, 2026 — classified as 5 injuries, 446 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (72 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 451 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892550 ↗
• MalfunctionSep 17, 2026No Display/Image

  The customer reported no image 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 50805891 ↗
• MalfunctionJul 9, 2026Activation Failure

  THE CUSTOMER REPORTED THAT IT IS BLINKING ALL OF THE LIGHTS ARE BLINKING INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761774 ↗
• MalfunctionMay 13, 2026No Device Output

  THE CUSTOMER REPORTED BLINKING LIGHTS DURING SET-UP INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THE CUSTOMER SUSPECTED THE PROBABLE CAUSE OF THE BLINKING LIGHTS WAS DUE TO SWITCH IN 12 O¿CLOCK POSITION THAT MAYBE ENGAGING WITHOUT THE SCOPE SEATED PROPERLY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162273 ↗
• MalfunctionMay 7, 2026Poor Quality Image; No Device Output

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED SPARE LAMP WAS NOT ON AND LAMP WAS VERY DIM. THE ISSUE WAS FOUND DURING GASTRODUODENOSCOPY DIAGNOSTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112885 ↗
• MalfunctionApr 20, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBIT BLINKING FRONT PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933646 ↗
• MalfunctionApr 2, 2026Display or Visual Feedback Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD POOR LIGHT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763286 ↗
• MalfunctionMar 25, 2026No Display/Image

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE WAS UNABLE TO OBTAIN A PICTURE ON THE MONITOR DURING A CYSTOSCOPY DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688294 ↗
• MalfunctionMar 18, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD INTERMITTENT IMAGE. 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 24635015 ↗
• MalfunctionMar 11, 2026No Device Output

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD STROBING LIGHT. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569382 ↗
• MalfunctionMar 5, 2026Output Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD FLASHING BULB UNTIL IT WENT OUT AND THE EMERGENCY BULB CAME ON. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518702 ↗
• MalfunctionFeb 24, 2026No Display/Image

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO IMAGE DURING SEDATION OF AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429476 ↗
• MalfunctionFeb 18, 2026Power Problem

  IT WAS REPORTED THE LIGHT SOURCE HAD NO POWER ON IT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384584 ↗
• MalfunctionFeb 11, 2026Failure to Power Up

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO POWER. 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 24314009 ↗
• MalfunctionFeb 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD THE FRONT PANEL FLASHING ON ALL FUNCTIONS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273477 ↗
• MalfunctionFeb 3, 2026Erratic or Intermittent Display

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246662 ↗
• MalfunctionJan 23, 2026Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168706 ↗
• MalfunctionJan 15, 2026Power Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE FAILED TO TURN ON. THERE WAS NO POWER TO THE UNIT. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087320 ↗
• MalfunctionDec 22, 2025Failure to Power Up; Physical Resistance/Sticking; Failure to Power Up; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LIGHT SOURCE HAD NO POWER AND THE POWER SWITCH WAS STUCK. 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 23871660 ↗
• MalfunctionDec 22, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD INTERMITTENT ISSUES WITH THE SPARE LAMP INDICATOR. THE ISSUE WAS FOUND BEFORE SEDATION OF A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863756 ↗
• MalfunctionDec 16, 2025No Display/Image; No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815643 ↗
• MalfunctionDec 4, 2025Unexpected Shutdown; Unexpected Shutdown

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713734 ↗
• MalfunctionNov 19, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD A BURNED-OUT LIGHT BULB. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595409 ↗
• MalfunctionNov 12, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED VARIABLE LIGHT. THE ISSUE OCCURRED DURING SEDATION OF AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531718 ↗
• MalfunctionOct 30, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DEBRIS INSIDE SOCKET AIR TUBING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426689 ↗