VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400 (UDI 04953170374531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170374531), received between Jan 3, 2022 and Sep 22, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Poor Quality Image

  The customer reported that the light source image was darkening during an unspecified procedure. During the initial evaluation of the device, no reportable malfunction was noted. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850402 ↗
• MalfunctionJan 9, 2026Break; Failure to Clean Adequately

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD THE LIGHT GUIDE ROD STUCK AND BROKEN. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027079 ↗
• MalfunctionJan 6, 2026Communication or Transmission Problem; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975349 ↗
• MalfunctionNov 24, 2025No Display/Image; No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638351 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THE TELESCOPE WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372291 ↗
• MalfunctionSep 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE XENON LIGHT SOURCE EXHIBITED A LOOSE SCOPE SOCKET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330478 ↗
• MalfunctionJun 4, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED DEVICE COULD NOT BE LIT DUE TO DEFECTIVE MAIN LAMP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464119 ↗
• MalfunctionMar 6, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED, THE LIGHT SOURCE THE, TRANSIENT RECEPTOR POTENTIAL CHANNEL (TPRC) LAMP IS BLINKING AND CONTINUES TO STAY ON AFTER IT HAS BEEN SWITCH OFF. THE ISSUE OCCURRED DURING THE PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846522 ↗
• MalfunctionOct 23, 2023Defective Component; Defective Component

  THERE WAS NO ERROR MESSAGE DISPLAYED. THE HIGH INTENSITY LEVER WAS THE ONLY INDICATOR OF AN ISSUE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE CUSTOMER¿S REPORTED ISSUE WAS OBSERVED. NO DELAY, AND THE STAFF WAS ABLE TO COMPLETE THE INTENDED PROCEDURE WAS THE SAME UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987708 ↗
• MalfunctionAug 9, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN INCOMING INSPECTION, THE VISERA 4K UHD XENON LIGHT SOURCE HAD THE EMERGENCY LAMP BLINKING. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492471 ↗
• MalfunctionJun 12, 2023Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE VISERA 4K UHD XENON LIGHT SOURCE DISPLAYED A DARK PICTURE. THE DEVICE DISPLAYED A CORRECT PICTURE ONLY IN HIGH MODE. THE DEVICE COULD NOT BE USED. THE CUSTOMER REPORTED THE ISSUE WAS IDENTIFIED DURING PREPARATION PRIOR TO USE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110904 ↗
• MalfunctionMay 15, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA 4K UHD XENON LIGHT SOURCE WHEN TURNED ON SHOWED ERROR 214 - SPARE LAMP ERROR. THE XENON LAMP WAS REMOVED. A SPARE LAMP WAS INSTALLED BUT WAS ALSO NOT TURNING ON. THE XENON LAMP WAS NOTED TO BE WORKING. THE ISSUE WAS FOUND DURING PREVENTATIVE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935030 ↗
• MalfunctionMar 30, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA 4K UHD XENON LIGHT SOURCE HAD A LAMP ERROR E214 SHOWING. THE SPARE LIGHT WAS BLINKING WHILE THE MAIN LIGHT WAS WORKING. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644905 ↗
• MalfunctionFeb 24, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA 4K UHD XENON LIGHT SOURCE EMERGENCY LAMP INDICATOR WAS BLINKING DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY. THE DOCTOR COMPLETED THE PROCEDURE USING THE SAME SET OF EQUIPMENT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438351 ↗
• MalfunctionJan 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS DURING A THERAPEUTIC LAPAROSCOPIC SURGERY, THE LIGHT PANEL WAS FLASHING AND A E104(LAMP ERROR) OCCURRED ON THE VISERA 4K UHD XENON LIGHT SOURCE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215862 ↗
• MalfunctionJan 12, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE, THE SPARE LAMP INDICATOR WAS BLINKING AND THE XENON LAMP WAS WORKING OKAY ON THE VISERA 4K UHD XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152690 ↗
• MalfunctionNov 10, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR A LAPAROSCOPE PROCEDURE, NO HIGH LIGHT MODE AND DARK IMAGE ON THE VISERA 4K UHD XENON LIGHT SOURCE. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, LAMP FAILURE WAS FOUND. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774159 ↗
• MalfunctionSep 2, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE USER FACILITY RETURNED AN ASSET VISERA 4K UHD 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 FLASHED. 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 15349539 ↗
• MalfunctionAug 5, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS DURING A LAPAROSCOPE PROCEDURE, THE LIGHT GUIDE (LG) WIRE COULD NOT BE PULLED OUT ON THE VISERA 4K UHD XENON LIGHT SOURCE. THERE WAS NO DELAY REPORTED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179987 ↗
• MalfunctionJan 3, 2022Failure to Power Up; Failure to Power Up

  A USER FACILITY REPORTED TO OLYMPUS THAT, THE (B)(6) LIGHT SOURCE FRONT PANEL LIGHT FLASHES. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13143074 ↗