VISERA Pro XENON LIGHT SOURCE OLYMPUS CLV-S40Pro (UDI 04953170228933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 04953170228933), received between Nov 20, 2020 and Sep 23, 2026 — classified as 158 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (42 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 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Failure

  The customer reported Main lamp does not ignite during inspection for use involving an Olympus xenon light source. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872468 ↗
• MalfunctionAug 2, 2025Optical Problem; Optical Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693782 ↗
• MalfunctionJun 6, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING MAINTENANCE, THE SUBJECT DEVICE EXHIBITED THAT THE MAIN LAMP WAS BLINKING AND MADE TISSUE INDISTINGUISHABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158336 ↗
• MalfunctionDec 11, 2024Display 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 20905902 ↗
• MalfunctionDec 9, 2024Power Problem; Power Problem

  IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED POWER SUPPLY FAILURE. THE ISSUE OCCURRED DURING SET UP, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878758 ↗
• MalfunctionNov 26, 2024Flare or Flash; Activation Failure; Flare or Flash; Activation Failure

  IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD PANEL FLASHES. THE ISSUE WAS FOUND, DURING A SET UP/INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789768 ↗
• MalfunctionNov 24, 2024No Device Output; No Device Output

  IT WAS REPORTED, ALL LEDS OF THE SUBJECT DEVICE FLASHED AT IRREGULAR INTERVALS, DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS PROLONGED LESS THAN 30 MINUTES, AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767941 ↗
• MalfunctionSep 26, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THE XENON LIGHT SOURCE TURNED ON, BUT THE LAMP DID NOT TURN ON. THE ISSUE OCCURRED BEFORE AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309167 ↗
• MalfunctionApr 24, 2024No Device Output; No Device Output

  IT WAS REPORTED THE LIGHT SOURCE, FRONT PANEL WAS BLINKING/FLASHING AND CONTINUING TURNING O. HERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171766 ↗
• MalfunctionApr 12, 2024Poor Quality Image; Noise, Audible; Poor Quality Image; Noise, Audible

  IT WAS REPORTED, THE LIGHT SOURCE HAD IMAGE NOISE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098487 ↗
• MalfunctionApr 11, 2024No Device Output; No Device Output

  IT WAS REPORTED THE XENON LIGHT SOURCE FRONT PANEL WAS FLICKERING. IT WAS NOT CONFIRMED WHEN THIS EVENT TOOK PLACE. ADDITIONAL DETAILS RELATING TO THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088353 ↗
• MalfunctionMar 29, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE LIGHT SOURCE HAD A BURNT INLET FUSE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008663 ↗
• MalfunctionMar 11, 2024Output Problem; Output Problem

  IT WAS REPORTED, THE XENON LIGHT SOURCE DOES NOT WORK. NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882868 ↗
• MalfunctionFeb 23, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE XENON LIGHT SOURCE HAD AN IMAGE ISSUE ON THE TOWER. POWERED ON UNIT AND SAW THAT THE "AUTO" LIGHT WAS NOT ON. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773399 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT SOURCE EXHIBITED THE INLET FUSE BOX BEING BURNT OUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707422 ↗
• MalfunctionJan 10, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE PRO XENON LIGHT SOURCE EMERGENCY LIGHTS ARE TURNED ON FREQUENTLY. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND DURING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486342 ↗
• MalfunctionJan 3, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE XENON LIGHT SOURCE HAD A BROKEN RECORDING WITH A DEFECTIVE LIGHT CABLE. IT WAS UNSPECIFIED WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440927 ↗
• MalfunctionDec 22, 2023Overheating of Device; No Visual Prompts/Feedback; Overheating of Device; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE LIGHT SOURCE OVERHEATED AND TURNED OFF. THE EMERGENCY LIGHT DID NOT COME ON. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387135 ↗
• MalfunctionDec 21, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE LIGHT SOURCE PANELS MAY LIGHT UP WHEN THE POWER IS TURNED ON. THE ISSUE WAS FOUND DURING INSPECTION FOR USE, FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377785 ↗
• MalfunctionDec 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE VISERA PRO XENON LIGHT SOURCE, WHEN TURNING ON THE POWER TO THE DEVICE, WHEN THE LIGHT IS TURNED ON, THE LAMP IS ABOUT 300 HOURS, BUT THE EMERGENCY LIGHT IS ON. IT WAS RESTORED BY RESTARTING. THE ISSUE OCCURRED DURING THE PREPARATION FOR USE. THE PROCEDURE WAS UNKNOWN AND IT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344432 ↗
• MalfunctionNov 15, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA XENON LIGHT SOURCE MAIN LAMP AND EMERGENCY LAMP DID NOT LIGHT. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE ON AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139028 ↗
• MalfunctionNov 7, 2023No Display/Image; Defective Component; No Display/Image; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS NO IMAGE WHEN THE ENDOSCOPE WAS CONNECTED AND THE LIGHT SOURCE WAS TURNED ON. IT WAS ALSO REPORTED THA THE FRONT PANEL COULD NOT BE OPERATED. THE ISSUE WAS FOUND DURING PREPARATION FOR USE OF AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO DELAYS OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089241 ↗
• MalfunctionOct 12, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA PRO XENON LIGHT SOURCE EMERGENCY LIGHTS TURNED ON. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918199 ↗
• MalfunctionOct 2, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA PRO XENON LIGHT SOURCE AND VISERA PRO VIDEO SYSTEM CENTER GENERATED SMOKE JUST PRIOR THE END OF THE EXAMINATION, AND IT WAS FURTHER NOTED THAT THE ENDOSCOPIC IMAGE HAD NO OUTPUT, RESULTING IN A BLACKOUT. THE ISSUE WAS FOUND DURING THE EXAMINATION AND WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO DELAY IN TREATMENT AND THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: (B)(6) VISERA PRO VIDEO SYSTEM CENTER FOR ADDITIONAL DEVICE REPORTED FOR SAME EVENT (B)(3).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858267 ↗
• MalfunctionSep 25, 2023Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA PRO XENON LIGHT SOURCE HAD RESTARTED DURING SURGERY. THE ISSUE OCCURRED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809257 ↗