EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190 (REF N4505841)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III gastroscope has 85 reports in the FDA database, with no deaths and no injuries recorded. Many reports describe the device failing to clean adequately, and others describe burned or melted plastic on the front end cover, with no patient involvement reported. There is 1 open recall, started in October 2024, over one disinfection method being removed from its instructions for use.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04953170437014), received between Jul 18, 2023 and Oct 15, 2025 — classified as 85 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (59 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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.
Reports received per month
Recalls naming this device
- Oct 31, 2024Class IIOpen, Classified
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Z-0620-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately59
- Microbial Contamination of Device11
- Thermal Decomposition of Device7
- Device Reprocessing Problem2
- Melted2
- Contamination1
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions85
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Melted; Melted
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A BURNT CAMERA COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303114 ↗MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701460 ↗MalfunctionMar 19, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED PLASTIC DISTAL END COVER, BENDING SECTION COVER, AND CONNECTING TUBE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21648602 ↗MalfunctionJan 30, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277457 ↗MalfunctionJan 27, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE PLASTIC DISTAL END COVER WAS BURNED. THE ISSUE OCCURRED DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240141 ↗MalfunctionDec 5, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED MELTING OF THE PLASTIC DISTAL END COVER AT FORCEPS PORT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852913 ↗MalfunctionNov 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE'S PLASTIC DISTAL END COVER HAD A BURN. THE ISSUE OCCURRED DURING INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706890 ↗MalfunctionOct 25, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER AND FOREIGN OBJECT IN THE FOLLOWING COMPONENTS: NOZZLE, ADHESIVE OF THE LIGHT GUIDE LENS, ADHESIVE OF THE OBJECTIVE LENS, AND PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539779 ↗MalfunctionOct 24, 2024Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE PROBE COVER WAS BURNT. IT'S UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20520822 ↗MalfunctionOct 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461164 ↗MalfunctionOct 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD A BURN ON THE PLASTIC DISTAL END COVER. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457981 ↗MalfunctionOct 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A WHITISH FOREIGN MATERIAL INSIDE THE AIR/WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391567 ↗MalfunctionOct 3, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE DISTAL END COVER WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20363598 ↗MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE NOZZLE BLOCKED BY FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238339 ↗MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED AIRWATER-TUBE AND AIRWATER-CYLINDER HAD WHITE FOREIGN MATERIAL INSIDE THE TUBES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238117 ↗MalfunctionSep 17, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE INSULATION RESISTANCE VALUE AT DISTAL END DID NOT MEET THE STANDARD VALUE DUE TO BURN ON PLASTIC DISTAL END COVER. ADDITIONALLY, AIR/WATER CYLINDER, AIR/WATER TUBE, ADHESIVE ON BENDING SECTION COVER, AND JET TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237159 ↗MalfunctionSep 13, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE AIR/WATER CHANNEL AND JET TUBE OF THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212182 ↗MalfunctionSep 3, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNSPECIFIED NUMBER OF STREPTOCOCCUS PARASANGUINIS, STREPTOCOCCUS SANGUINIS, AND STREPTOCOCCUS VESTIBULARIS. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. 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 20124936 ↗MalfunctionAug 22, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039109 ↗MalfunctionAug 22, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20033014 ↗MalfunctionAug 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE CHANNEL TUBE. ADHESIVE ON BENDING SECTION COVER AND BETWEEN PLASTIC DISTAL END COVER AND DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19956452 ↗MalfunctionAug 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19924495 ↗MalfunctionJul 23, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNKNOWN COLONY FORMING UNITS (CFUS) OF AN UNKNOWN MICROBES. 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 19813194 ↗MalfunctionJul 19, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 14 COLONY FORMING UNITS (CFUS) OF KLEBSIELLA GROUPE PNEUMONIAE AND 46 CFUS OF ENTEROBACTER CLOACAE COMPLEX. 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 19780740 ↗MalfunctionJul 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE AIR/WATER CYLINDER, ON THE DISTAL END COVER, ON THE BENDING SECTION COVER, AND ON THE BENDING SECTION COVER ADHESIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19757705 ↗
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-0498-2025 · Sep 18, 2024 · Open, ClassifiedBrand 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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