VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR (UDI 04953170428142)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04953170428142), received between Jan 17, 2021 and Aug 15, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024No Device Output; No Device Output

  IT WAS REPORTED THE XENON LIGHT SOURCE HAD THE LIGHTS WORKING HOWEVER THE PANEL BUTTONS WERE FLASHING. THE ISSUE WAS FOUND DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THERE WERE NO DELAYS REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990144 ↗
• MalfunctionApr 3, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED, THE XENON LIGHT SOURCE¿S FRONT PANEL FLICKERED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035692 ↗
• MalfunctionApr 2, 2024Output Problem; Output Problem

  IT WAS REPORTED, THE XENON LIGHT SOURCE FRONT PANEL FLICKERS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020295 ↗
• MalfunctionMar 11, 2024Noise, Audible; Noise, Audible

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED ABNORMAL NOISE DUE TO FRONT PANEL INTERNAL SCREWS ARE DETACHED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873665 ↗
• MalfunctionFeb 5, 2024No Device Output; No Device Output

  THE COSTUMER REPORTED THAT THERE WAS NO DELAY AND PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640521 ↗
• MalfunctionJan 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE LIGHT SOURCE FRONT PANEL FLICKERED. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443029 ↗
• MalfunctionDec 13, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE FRONT PANEL OF THE XENON LIGHT SOURCE WAS FLASHING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322071 ↗
• MalfunctionNov 3, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE, THE VISERA ELITE II XENON LIGHT SOURCE WHEN TURNED ON, ITS EMERGENCY LAMP WOULD BLINK BUT THE LAMP DOES NOT SWITCH ON. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064458 ↗
• MalfunctionOct 31, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE II XENON LIGHT SOURCE HAD A E207 SPARE LAMP ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041867 ↗
• MalfunctionOct 31, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE XENON LIGHT SOURCE FRONT PANEL FLICKERED DUE TO THE FIXING SCREW MOTOR ON TURRET WAS DETACHED. THE EVENT WHERE THE ISSUE WAS FOUND IS UNKNOWN. THERE WAS NO DELAY AND THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041258 ↗
• MalfunctionJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE VISERA ELITE II XENON LIGHT SOURCE SHOWED ERROR E112. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND DETACHMENT OF THE SCREWS ON THE FILTER TURNTABLE. THERE WAS NO REPORT OF DELAY OR HARM TO A PATIENT OR USER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249139 ↗
• MalfunctionJun 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A CUSTOMER REPORTED THAT DURING INSPECTION BEFORE USE, ERROR CODE E207 (CLV SPARE LAMP ERROR) WAS SHOWN AND THEN "THE ERROR WAS CLOSED" ON THE VISERA ELITE II XENON LIGHT SOURCE. AN UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211035 ↗
• MalfunctionJun 6, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE DEFECT WAS FOUND DURING INSPECTION BEFORE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075579 ↗
• MalfunctionMay 15, 2023Output Problem; Output Problem

  IT WAS REPORTED TO OLYMPUS FIELD SERVICE ENGINEER (FSE), THAT THE VISERA ELITE II XENON LIGHT SOURCE FRONT PANEL WAS BLINKING. AND CONTINUED TURNING ON. IT WAS ALSO NOTED, THAT THE EMERGENCY LAMP INDICATOR WAS BLINKING, AND MADE AN ABNORMAL SOUND. THE ISSUES WERE FOUND DURING MAINTENANCE OF THE DEVICE AT THE SITE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935315 ↗
• MalfunctionDec 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE, A E207(EMERGENCY LAMP IS BLOWN OR FAILED) AND SPARE LAMP INDICATION GLOWING ON THE VISERA ELITE II XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995796 ↗
• MalfunctionDec 15, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE FIELD SERVICE ENGINEER (FSE) REPORTED TO OLYMPUS, THE PANEL ON THE SPARE VISERA ELITE II XENON LIGHT SOURCE WAS BLINKING. THE DEVICE WAS CLEANED MANUALLY WITH ALCOHOL. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988268 ↗
• MalfunctionNov 17, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT WHILE PERFORMING A LAPAROSCOPIC SURGERY USING AN OLYMPUS VISERA ELITE II XENON LIGHT SOURCE & VISERA ELITE II VIDEO SYSTEM CENTER, WHEN CHANGING TO OBSERVATION MODE, THE SCREEN WENT BLACK. ACCORDING TO THE INITIAL REPORTER, THE STAFF RESTARTED BOTH DEVICES, THE IMAGE WAS RESTORED, AND HE CONTINUED THE PROCEDURE WITHOUT ANY OTHER ISSUES OR IMPACTS TO THE PATIENT. THIS IS REPORTER 1 OF 2, BEING SUBMITTED TO CAPTURE THE VISERA ELITE II XENON LIGHT SOURCE. FOR DETAILS RELATING TO THE VISERA ELITE II VIDEO SYSTEM CENTER, PLEASE SEE REPORT 2 OF 2 WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813924 ↗
• MalfunctionNov 7, 2022Mechanical Problem; Mechanical Problem

  THE USER FACILITY RETURNED AN ASSET VISERA ELITE II XENON LIGHT SOURCE TO OLYMPUS TO THE SERVICE CENTER. THE USER FACILITY DID NOT REPORT A MALFUNCTION WITH THE DEVICE. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, THE FRONT PANEL FLICKERS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748259 ↗
• MalfunctionOct 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE VISERA ELITE II XENON LIGHT SOURCE INTERNAL GEAR IS FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633680 ↗
• MalfunctionSep 16, 2022Failure to Power Up; Failure to Power Up

  THE USER FACILITY RETURNED AN ASSET VISERA ELITE II XENON LIGHT SOURCE TO OLYMPUS TO THE SERVICE CENTER. THE USER FACILITY DID NOT REPORT A MALFUNCTION WITH THE DEVICE. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, THE DEVICE DOES NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439898 ↗
• MalfunctionJul 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THE VISERA ELITE II XENON LIGHT SOURCE FRONT PANEL IS BLINKING. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090560 ↗
• MalfunctionJul 20, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, NO LIGHT AND IT DOES NOT EXECUTE SOME COMMANDS 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 15067028 ↗
• MalfunctionFeb 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE LIGHT SOURCE WAS NOT WORKING. UPON INSPECTION OF THE DEVICE BY A FIELD SERVICE ENGINEER, IT WAS DETERMINED THE EMERGENCY LAMP INDICATOR WAS BLINKING. THE PROBLEM OF "LIGHT SOURCE WAS NOT WORKING," AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545037 ↗
• MalfunctionJan 17, 2021Break; Break

  DURING THE CHECK OF THE DELIVERY OF THE DEVICE, THE LIGHT SOURCE CABLE COULD NOT CONNECT TO THE DEVICE. THE LIGHT SOURCE CABLE CANNOT BE SECURED TO THE DEVICE AND THE LIGHT SOURCE CABLE DISCONNECTS FROM THE DEVICE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11183617 ↗