EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190 (REF N4505842)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170452475), received between Oct 17, 2024 and Jun 25, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K232997); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619939 ↗
• MalfunctionMay 29, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE AIR/WATER CHANNEL HAD FOREIGN MATERIAL. THE ROOT CAUSE OF THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334151 ↗
• MalfunctionApr 16, 2026Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897137 ↗
• MalfunctionApr 6, 2026Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A BURNT DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790901 ↗
• MalfunctionMar 30, 2026Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE DISTAL SHEATH OF THE GASTROINTESTINAL VIDEOSCOPE WAS MELTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730362 ↗
• MalfunctionMar 20, 2026No Display/Image

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE IS SHOWING NO IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648727 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A CLIP COMING OUT OF IT DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536769 ↗
• MalfunctionFeb 25, 2026Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BURNT PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445534 ↗
• MalfunctionFeb 13, 2026Poor Quality Image; Overheating of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BURNT COVER INSULATION AND A BURNT DISTAL END OF THE PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335441 ↗
• MalfunctionJan 30, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE RESIDUE INSIDE THE NOZZLE AND THE CONTROL BODY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225975 ↗
• MalfunctionJan 22, 2026No Display/Image

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144440 ↗
• MalfunctionDec 23, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED DUE TO CLOG WITH WHITE RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878211 ↗
• MalfunctionDec 16, 2025Flare or Flash; Flare or Flash

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURNED COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821965 ↗
• MalfunctionDec 12, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE IMAGE WAS GRAINY WHEN HOOKED UP TO THE PROCESSOR. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786486 ↗
• MalfunctionDec 5, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE RESIDUES IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731664 ↗
• MalfunctionOct 15, 2025Flare or Flash; Flare or Flash

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD A BURNT DISTAL TIP. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299295 ↗
• MalfunctionAug 26, 2025Poor Quality Image; Residue After Decontamination; Poor Quality Image; Residue After Decontamination

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD BLURRY VISION. IT IS UNKNOWN WHEN THIS MALFUNCTION OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896560 ↗
• MalfunctionJun 6, 2025Loss of or Failure to Bond; Device Contamination with Chemical or Other Material; Loss of or Failure to Bond; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAS GLUE IN IT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22159423 ↗
• MalfunctionOct 17, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, AFTER A MICROBIOLOGICAL ROUTINE CONTROL, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR >200 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX MICROORGANISMS AND STENOTROPHOMONAS MALTOPHILIA. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232997. One submission often covers many models, so check the product and lot details in each record.

• Z-0620-2025 · Oct 31, 2024 · Open, Classified
  EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
• Z-0498-2025 · Sep 18, 2024 · Open, Classified
  Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This