VISERA XENON LIGHT SOURCE CLV-S45 (UDI 04953170275753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170275753), received between Dec 15, 2020 and Jan 8, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108335 ↗
• MalfunctionJul 18, 2024Signal Artifact/Noise; Poor Quality Image; Signal Artifact/Noise; Poor Quality Image

  IT WAS REPORTED THAT NOISE APPEARED IN THE IMAGE OF THE LIGHT SOURCE. THE ISSUE OCCURRED DURING PREPARATION FOR THE DIAGNOSTIC CYSTOSCOPY. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777055 ↗
• MalfunctionJun 13, 2024Noise, Audible; No Visual Prompts/Feedback; Noise, Audible; No Visual Prompts/Feedback

  IT WAS REPORTED THE LAMP OF THE XENON LIGHT SOURCE DID NOT LIGHT UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527876 ↗
• MalfunctionJun 2, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE'S EMERGENCY LIGHTS HAD BEEN SWITCHED ON AND THE FAN TURNED ON AND OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIC DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444782 ↗
• MalfunctionApr 18, 2024No Device Output; No Device Output

  THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140852 ↗
• MalfunctionMar 22, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED, THE XENON LIGHT SOURCE POWER DOES NOT TURN ON. THE ISSUE FOUND AFTER EXAMINATION FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE.. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958995 ↗
• MalfunctionDec 7, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE XENON LIGHT SOURCE EMERGENCY LIGHT SOURCE TURNS ON OCCASIONALLY. THE ISSUE WAS FOUND DURING INSPECTION AT THE USE. THE INTENDED DIAGNOSTIC PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283153 ↗
• MalfunctionNov 21, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA XENON LIGHT SOURCE AUTOMATIC DIMMING DID NOT WORK. IT WAS PITCH BLACK DURING THE INSTALLATION AND IT IMPROVED A LITTLE WHEN THE DIMMING CABLE WAS MANIPULATED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184623 ↗
• MalfunctionJul 31, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THE MAIN LAMP OF THE VISERA XENON LIGHT SOURCE DID NOT TURN ON. THE ISSUE OCCURRED DURING A THERAPEUTIC THORACOSCOPIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THE CUSTOMER NOTED THE LAMP HAD BEEN REPLACED THE PREVIOUS WEEK. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424054 ↗
• MalfunctionJul 27, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS VISERA XENON LIGHT SOURCE WAS EXPERIENCING AN UNSPECIFIED LAMP MALFUNCTION. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409853 ↗
• MalfunctionJun 15, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THERE WAS AN INTERMITTENT BLACK SCREEN IN THE IMAGE WHEN USING THE VISERA XENON LIGHT SOURCE. THE ISSUE WAS FOUND DURING REPROCESSING BEFORE USE FOR A DIAGNOSTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, WHICH WAS FINISHED WITHOUT DELAY WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136390 ↗
• MalfunctionMay 18, 2023Defective Component; Defective Component

  WHILE PERFORMING ROUTINE MAINTENANCE ON AN OLYMPUS VISERA XENON LIGHT SOURCE DEVICE. IT WAS DISCOVERED, THAT THE LAMP HOURS HAD BEEN EXCEEDED AND THE LAMP REQUIRED REPLACEMENT. FOLLOWING THE REPLACEMENT OF THE LAMP, THE USER WAS UNABLE TO RESET THE LAMP HOUR. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS THEN DISCOVERED, THAT THE SPARE LAMP INDICATOR WAS BLINKING, DUE TO A DEFECTIVE SPARE LAMP. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DEFECTIVE SPARE LAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952812 ↗
• MalfunctionMay 16, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA ELITE XENON LIGHT SOURCE, THE LAMP SWITCHES TO EMERGENCY LIGHT EVEN AFTER LAMP REPLACEMENT. THE ISSUE OCCURRED AFTER THE DEVICE WAS TURNED ON. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939611 ↗
• MalfunctionApr 4, 2023Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT A FLATTENED FRONT PANEL OF THE VISERA XENON LIGHT SOURCE WAS NOTED. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, COMMUNICATION FAILURE DUE TO A FAULTY MAIN BOARD WAS OBSERVED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678693 ↗
• MalfunctionMar 9, 2023No Device Output; No Device Output

  A CUSTOMER REPORTED TO OLYMPUS, THE VISERA XENON LIGHT SOURCE WHEN THE POWER WAS TUNED ON, THE FRONT PANEL FLASHES. THE UNSPECIFIED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514109 ↗
• MalfunctionFeb 17, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING RENAL PELVIS/BLADDER EXAMINATION, THE FRONT PANEL OF THE VISERA XENON LIGHT SOURCE FLASHED WHEN POWER WAS TURNED ON AND AN ALERT SOUND WAS GENERATED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401102 ↗
• MalfunctionFeb 14, 2023Optical Problem; Optical Problem

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE VISERA XENON LIGHT SOURCE EMERGENCY LIGHT WAS ON. THE UNSPECIFIED DIAGNOSTIC PROCEDURE WAS DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376117 ↗
• MalfunctionFeb 5, 2023Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THAT ABNORMAL LIGHTING ON THE FRONT PANEL OF THE VISERA XENON LIGHT SOURCE WAS NOTED. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301954 ↗
• MalfunctionJan 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, ALL THE LAMPS ON THE VISERA XENON LIGHT SOURCE KEEP BLINKING WHEN THE POWER IS TURNED ON DURING THE PRE-USE INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16175704 ↗
• MalfunctionDec 31, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THE VISERA XENON LIGHT SOURCE PANEL LIGHTS ARE FLASHING AND BEEPS. 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 16081209 ↗
• MalfunctionDec 20, 2022Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT. THE INTENDED PROCEDURE WAS A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY AND THERE WAS NO DELAY IN THE PROCEDURE AND WAS COMPLETED WITH THE SUBJECT DEVICE. LTF-VP, OTV-S7 AND OEV191 WERE ALSO BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019283 ↗
• MalfunctionDec 6, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE MAIN LAMP DOES NOT LIGHT UP. EMERGENCY LIGHTS DON¿T WORK EITHER (BOTH LAMPS A AND B DO NOT WORK) ON THE VISERA XENON LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926624 ↗
• MalfunctionOct 5, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE EMERGENCY LIGHT OF THE SUBJECT DEVICE WAS BLINKING. THE REPORTED ISSUE WAS OBSERVED DURING THE DEVICE INSPECTION VISIT. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547489 ↗
• MalfunctionOct 5, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  A USER FACILITY REPORTED TO OLYMPUS THAT THE FRONT PANEL SWITCHES DID NOT FUNCTION. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING A DEVICE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546449 ↗
• MalfunctionSep 13, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON 21-SEP-2022: THE EVENT OCCURRED WHILE USING IT ON (B)(6) 2022. THERE WAS NO DELAY IN PROCEDURE AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415032 ↗