VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR (UDI 04953170386138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170386138), received between Jan 7, 2022 and Aug 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Circuit Failure; Circuit Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DAMAGED PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877864 ↗
• MalfunctionMay 2, 2025Intermittent Loss of Power; Intermittent Loss of Power

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954661 ↗
• MalfunctionJul 17, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE II XENON LIGHT SOURCE HAD THE POWER COMPLETELY CUT OFF WITH THE POWER CABLE FALLING OUT. THE CUSTOMER SUSPECTED THIS WAS DUE TO LOOSENING OF THE PLUG-IN CONNECTOR DUE TO VIBRATION WHEN MOVING THE TROLLEY AND THE PULLING FORCE OVER TIME. THE ISSUE WAS FOUND DURING THE RIGHT PARTIAL LUNG RESECTION AND MEDIASTINAL LYMPH NODE BIOPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED AS THE POWER CORD WAS REINSERTED TO CONTINUE. THE FOLLOWING COMPLAINTS ARE RELATED: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333893 ↗
• MalfunctionJan 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE PANEL FLICKERED ON THE VISERA ELITE II XENON LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16212568 ↗
• MalfunctionMay 9, 2022No Display/Image; No Display/Image

  A USER FACILITY REPORTED TO OLYMPUS THAT EASY PORT 1 OF THE BOOM WAS NOT WORKING (NO VIDEO IMAGE). THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337834 ↗
• MalfunctionMar 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THE VISERA ELITE II XENON LIGHT SOURCE DISPLAY IS FLASHING AND THERE IS NO LIGHT OUTPUT. THE EVENT WAS FOUND DURING RECEIPT INSPECTION AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13954129 ↗
• MalfunctionMar 29, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE VISERA ELITE II XENON LIGHT SOURCE MAIN LAMP AND SPARE LIGHT FAILS TO TURN ON. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943102 ↗
• MalfunctionMar 9, 2022Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE VISERA ELITE II XENON LIGHT SOURCE IMAGE BECAME TOO DARK AND BLACKED OUT. IN ADDITION, THE LAMP WAS OFF. THE EVENT OCCURRED DURING A CHEST PROCEDURE AND A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713332 ↗
• MalfunctionJan 7, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THAT DURING PREPARATION FOR USE, THE LIGHT SOURCE WAS NOT WORKING IN THE OPTICAL DIGITAL MODE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196852 ↗