Xenon Lamp MD-631Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04953170355950), received between Jun 7, 2018 and Feb 3, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Output 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Output Problem

  IT WAS REPORTED THAT THE XENON LAMP E103 ERROR OCCURRED. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248326 ↗
• MalfunctionDec 29, 2025Output below Specifications; Output below Specifications

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908480 ↗
• MalfunctionOct 28, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE XENON LAMP WENT DARK AFTER ABOUT 50 HOURS OF USE. THE EVENT OCCURRED DURING SEDATION FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408314 ↗
• MalfunctionSep 30, 2025Output Problem; Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23184510 ↗
• MalfunctionMay 28, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO OTHER UPDATED INFORMATION FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097252 ↗
• MalfunctionApr 24, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD LIGHTS OUT. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903771 ↗
• MalfunctionAug 28, 2024No Device Output; No Device Output

  IT WAS REPORTED THE LAMP EMERGENCY LIGHT CAME ON UNINTENTIONALLY WHEN THE LAMP WAS TURNED ON. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091313 ↗
• MalfunctionAug 14, 2024Output Problem; Output Problem

  IT WAS REPORTED, THE XENON LAMP DISPLAYED ERROR E102 (THE LIGHT SOURCE HAS BROKEN DOWN). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988552 ↗
• MalfunctionApr 24, 2024Poor Visibility; Poor Visibility

  IT WAS REPORTED THE XENON LAMP IMAGE WAS PARTICULARLY DARK AND DIFFICULT TO DISCERN WHEN USING NARROW BAND IMAGING (NBI). THE OBSERVATION WAS DISTURBED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175677 ↗
• MalfunctionNov 28, 2023Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER REPORTED THAT DURING A PRE-USE INSPECTION, HIS OLYMPUS XENON LAMP WAS IN AN ¿UNSTABLE CONDITION¿. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS PERIODICALLY NOT LIGHTING UP. REPORTEDLY, THE INTENDED PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18216014 ↗
• MalfunctionNov 13, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE LIGHT INTENSITY OF THE XENON LAMP DECREASED EVEN THOUGH THE LIFE METER HAD NOT REACHED 500 HOURS. THE ISSUE OCCURRED DURING A UNKNOWN DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118908 ↗
• MalfunctionMar 3, 2023Gas Output Problem; Gas Output Problem

  THE END USER FACILITY CONTACTED OLYMPUS TO REPORT THAT THEIR XENON LAMP IS OUT OF GAS AT 200 HOURS OF USE. A PREVIOUS REPORT FOR THIS DEVICE CAN BE REFERENCED WITH PATIENT IDENTIFIER (B)(6). NO PATIENT OR USER HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478160 ↗
• MalfunctionDec 23, 2022Loss of Power; Loss of Power

  IT WAS REPORTED TO OLYMPUS THAT THE XENON LAMP HAD AN E102 ERROR WHEN THE DEVICE WAS ACTIVATED. IT WAS NOTED THAT A POPPING SOUND OCCURRED AND THE EMERGENCY LIGHT TURNED ON. THE PROCEDURE WAS AN OTOLARYNGOLOGY ENDOSCOPY AND WAS COMPLETED USING THE EMERGENCY LIGHTS. THE LAMP WAS REPLACED THIS YEAR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043135 ↗
• MalfunctionOct 31, 2022Optical Problem; Optical Problem

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THAT DURING PRE-USE INSPECTION OF THE CLV-S190, PRIOR TO AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE LIGHTING LAMP (XENON LAMP) WOULD NOT LIGHT UP (IT WAS DARK), ALTHOUGH THE USAGE TIME DISPLAYED 200 HOURS. THE ISSUE WAS DETERMINED TO BE WITH THE SUBJECT DEVICE (XENON LAMP), BECAUSE A NEW XENON LAMP LIT UP WITHOUT ANY PROBLEMS WHEN INSTALLED IN THE CLV-S190. ANOTHER DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT ANY DELAYS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15701935 ↗
• MalfunctionOct 24, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THAT DURING THE PRE-USE INSPECTION, ERROR E102 (CLV LAMP ERROR) WAS DISPLAYED ON THE OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER. THE ISSUE WAS RESOLVED BY RESTARTING THE EQUIPMENT, AND THE INSPECTION WAS CARRIED OUT AS SCHEDULED. THE DIAGNOSTIC ENDOSCOPY WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659900 ↗
• MalfunctionAug 5, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT UPON POWERING ON AN OLYMPUS, MODEL CLV-S190, THERE WAS NO ILLUMINATION LIGHT. AFTER REPLACING THE LAMP, ILLUMINATION LIGHT WAS PRESENT. THE PROBLEM, 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 15175394 ↗
• MalfunctionJul 8, 2022No Device Output; No Device Output

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE AMOUNT OF LIGHT EMITTING FROM THE DEVICE WAS DECREASED. THE DEVICE WAS DEFECTIVE AS LIGHT EMITTED WAS INSUFFICIENT AFTER ONLY 300 HOURS OF USAGE. THE INSUFFICIENT LIGHT HAD THE POTENTIAL OF HINDERING A PROCEDURE. THERE ARE NO PATIENTS IMPACTED BY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957646 ↗
• MalfunctionMay 26, 2022Emergency Power Failure; Emergency Power Failure

  THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE LIGHT SOURCE LAMP SWITCHED TO AN EMERGENCY LIGHT. THE MAIN LAMP COULD NOT BE TURNED ON AGAIN, THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14506166 ↗
• MalfunctionApr 11, 2022Optical Problem; Optical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THEIR XENON LAMP WOULD NOT ILLUMINATE DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS DELAYED ROUGHLY "FIFTH TEEN" (15) MINUTES TO ALLOW PHYSICIAN SWITCH OUT THE DEVICE TO CONCLUDE THE CASE. ADDITIONALLY, AN FIELD SERVICE ENGINEER (FSE) WAS REQUESTED TO SERVICE THE UNIT. THERE WERE NO REPORTS OF DEATH, HARM OR INJURIES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075568 ↗
• MalfunctionFeb 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE USER IS USING OTV-S190 AND CLV-S190 IN COMBINATION. A CLV LAMP LIGHTING FAILURE ERROR E103 OCCURRED WHEN POWER IS TURNED ON. THE USER POWER OFF AND TURN ON THE DEVICE AND WHEN IT STARTS UP WITHOUT ANY PROBLEM, AN ERROR E102 OCCURRED. THE USER REPLACED THE LAMP WITH A SPARE LAMP AND THE ERROR DISAPPEARED. THE CUSTOMER STATED THAT THE SUBJECT LAMP HAS BEEN USED FOR ABOUT 100 HOURS. THE ISSUE FOUND AT PREPARATION FOR USE. THERE IS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546550 ↗
• MalfunctionFeb 10, 2022Output Problem; Output Problem

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, FOR THE BRAND NEW DEVICE THE INDOCYANINE GREEN (ICG) OBSERVATION WAS DARK DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE DAME DEVICE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509699 ↗
• MalfunctionJan 12, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE UPPER ENDOSCOPY, THE ENDOSCOPIC IMAGE WAS DARK AND THE EXAMINATION WAS INTERRUPTED. IT HAD BEEN DARK SINCE THE CLV-260NBI LAMP (MD-631) WAS REPLACED IN EARLY DECEMBER, BUT THIS TIME IT WAS JUDGED THAT IT WAS TOO DARK TO OBSERVE, AND THE PROCEDURE WAS PUT OFF AT A LATER DATE. IT WAS SAID THAT THERE WAS A PROBLEM WITH THE LAMP THAT WAS REPLACED LAST TIME BECAUSE IT IMPROVED AFTER SWITCHING TO ANOTHER LAMP IN THE FACILITY INVENTORY. IT WAS SAID THAT THE LAMP BECAME SO DARK THAT THE TISSUE COULD NOT BE IDENTIFIED AFTER USING IT FOR ABOUT 10 HOURS AFTER REPLACEMENT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234821 ↗
• MalfunctionJan 11, 2022Output below Specifications; Output below Specifications

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE PREPARATION FOR USE, MD-631 XENON LAMP USED FOR THE CLV-S40PRO HAD A LARGE DROP IN LIGHT INTENSITY AFTER A USAGE TIME OF ABOUT 200 HOURS. WHEN INSIDE OF THE LAMP WAS CHECKED, IT WAS BLACK. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222683 ↗
• MalfunctionNov 1, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE INSPECTION BEFORE USE, IT WAS FOUND THAT THE SUBJECT DEVICE (EXAMINATION LAMP) USED BY INCORPORATING IT INTO THE LIGHT SOURCE CLV-S40PRO MIGHT OR MIGHT NOT LIGHT UP. THE USER REPLACED THE SUBJECT DEVICE TO ANOTHER LAMP TO PERFORM THE INTENDED PROCEDURE. THE SUBJECT DEVICE HAD BEEN USED FOR LESS THAN 200 HOURS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727938 ↗
• MalfunctionJan 25, 2021Defective Device; Defective Device

  IT WAS REPORTED AM OLYMPUS XENON LAMP WAS DARK/DIM DURING A NARROW BAND IMAGING (NBI) PROCEDURE. THE LAMP WAS USED FOR 100 HOURS AND THE LIGHT INTENSITY WAS ABOUT 300 LUX. NO INFORMATION REGARDING PATIENT IMPACT WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11228109 ↗