Digtal light source cable MAJ-1933Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170304972), received between Sep 8, 2019 and Sep 21, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (6 reports).

8 other recalls cover devices cleared under the same FDA submission (K131780); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026No Display/Image

  The customer reported Image is not coming during an Inspection for use involving an Olympus digital light source cable. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843040 ↗
• MalfunctionSep 9, 2026Disconnection; No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699182 ↗
• MalfunctionAug 6, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158154 ↗
• MalfunctionJun 24, 2026Poor Quality Image

  THE CUSTOMER REPORTED IMAGE NOISE THAT MAKES THE SCREEN UNVIEWABLE DURING MAINTENANCE OF AN OLYMPUS DIGITAL LIGHT SOURCE CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611858 ↗
• MalfunctionApr 9, 2026Display or Visual Feedback Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832319 ↗
• MalfunctionMar 13, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DIGITAL LIGHT SOURCE CABLE EXHIBITED CABLE IS NOT TRANSMITTED AN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594423 ↗
• MalfunctionDec 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820772 ↗
• MalfunctionOct 17, 2025No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323896 ↗
• InjuryJan 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PROCEDURE WAS POSTPONED 35 MINUTES, PRIOR TO THE PATIENT BEING SEDATED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274108 ↗
• InjuryJan 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PROCEDURE WAS POSTPONED 35 MINUTES, PRIOR TO THE PATIENT BEING SEDATED. THERE WERE NO REPORTS OF PATIENT HARM. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE COMPLAINT INVESTIGATION. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, UPON FURTHER FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE, THUS CORRECTING B1, B2, AND F10. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. THE F10 MEDICAL DEVICE PROBLEM REPORTED WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NOT RETURNED TO OLYMPUS. THE CUSTOMER'S COMPLAINT WAS CONFIRMED BASED ON THE REMOTE SERVICE INSPECTION CONDUCTED BY THE TECHNICAL ASSISTANCE CENTER (TAC), HOWEVER, A CONCLUSIVE FINDING CANNOT BE CONFIRMED. BASED ON THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274080 ↗
• MalfunctionJul 7, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), WHEN THE DIGITAL LIGHT SOURCE CABLE WAS USED WITH THE CLV-190 (EVIS EXERA III LIGHT SOURCE), THERE WAS NO IMAGE ON THE SCREEN. SUBSEQUENTLY, THE CABLE WAS SWITCHED, AND THE ISSUE WAS RESOLVED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES RELATED EVENT WITH EVIS EXERA III LIGHT SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277234 ↗
• MalfunctionOct 28, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III VIDEO SYSTEM CENTER LOST THE IMAGE, THEN IT RETURNED. IT WAS FOUND THAT THE MAJ-1933 DIGITAL LIGHT SOURCE CABLE WAS THE CAUSE OF THE IMAGE LOSS. THE ISSUE WAS FOUND DURING AN ENDOSCOPY PROCEDURE AND THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692196 ↗
• MalfunctionSep 8, 2019Power Problem; Power Problem

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED WITH AN EVIS LUCERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-290SL AND EVIS LUCERA ELITE VIDEO SYSTEM CENTER OLYMPUS CV-290. IN THE PROCEDURE, THE CLV-290SL WAS TURNED OFF TWICE. AT THE FIRST TIME THE CLV-290SL WAS TURNED OFF, A WARNING MESSAGE WITH INSTRUCTIONS ON HOW TO CLEAN IT WAS DISPLAYED. AT THE SECOND TIME THE CLV-290SL WAS TURNED OFF, THE PATIENT WAS HAVING A BLEED. THE INTENDED PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY REPORTED. HOWEVER, THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER ENDOSCOPIC ROOM WHILE THE FAILURE PHENOMENON OCCURRED. AS AN EVALUATION RESULT BY AN OLYMPUS LOCAL SERVICE ENGINEER AFTER THE EVENT, THERE WAS NO FAULT WAS FOUND WITH THE CLV-290SL AND THE CV-290 AND IT WAS IDENTIFIED THAT THE FAULT IS WITH THE SUBJECT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8973420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.

• Z-1210-2024 · Jan 11, 2024 · Open, Classified
  Colonoscope, Model Number PCF-H190DL.
• Z-0419-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0418-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0416-2024 · Oct 16, 2023 · Open, Classified
  GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0415-2024 · Oct 16, 2023 · Open, Classified
  CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
• Z-0417-2024 · Oct 16, 2023 · Open, Classified
  GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0341-2024 · Sep 25, 2023 · Open, Classified
  Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
• Z-0056-2025 · Sep 14, 2023 · Open, Classified
  EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil