VISERA 4K UHD XENON LIGHT SOURCERecalls & reported problems across all models

We found 2 models of VISERA 4K UHD XENON LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Apr 24, 2020 and Sep 28, 2026 — classified as 6 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VISERA 4K UHD XENON LIGHT SOURCE problems

VISERA 4K UHD XENON LIGHT SOURCE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  157 reports
• VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  20 reports

Recent VISERA 4K UHD XENON LIGHT SOURCE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924030 ↗
• 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 ↗
• MalfunctionSep 21, 2026Loose or Intermittent Connection; Poor Quality Image

  The customer reported camera was dark and the prong pops out with an Olympus xenon light source. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837407 ↗
• MalfunctionSep 8, 2026No Device Output; Activation Failure; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679302 ↗
• MalfunctionSep 2, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569751 ↗
• MalfunctionMay 23, 2026Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD A LOOSE INTERNAL PISTON. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263734 ↗
• MalfunctionMay 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE WAS NOT BRIGHT. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDO NASAL PROCEDURE THAT WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083268 ↗
• MalfunctionApr 28, 2026No Device Output

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED FRONT PANEL LIGHTS BLINKING AND IRIS UNIT WORKING INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016819 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE EXHIBITED LEVEL FOR HIGH INTENSITY SWITCH IS BROKEN OR DAMAGE, FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983633 ↗
• MalfunctionApr 16, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD DAMAGED FAN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898649 ↗
• MalfunctionApr 13, 2026Optical Problem

  IT WAS REPORTED THAT THE XENON LIGHT SOURCE DISPLAYED INSUFFICIENT OUTPUT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858834 ↗
• MalfunctionMar 16, 2026Naturally Worn; Optical Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD A WORN-OUT SOCKET SLIDER SWITCH AND A FAILURE OF THE HIGH-INTENSITY MODE SWITCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610249 ↗
• MalfunctionFeb 24, 2026Power Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THE XENON LIGHT SOURCE HAD A STUCK AND COMPLETELY DEPRESSED POWER BUTTON AND WILL NOT POWER ON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436951 ↗
• MalfunctionJan 13, 2026Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055568 ↗
• 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 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports