EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190 (REF N4505840)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG · Class 2
All models of EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III videoscope is a flexible endoscope. Many of its 1,089 reports describe poor cleaning during reprocessing, and some describe contamination or foreign objects inside the scope. The reports include 6 deaths and 38 injuries. Reports rose to 475 in the last 12 months from 185 in the previous 12 months. Four open recalls cover unclear cleaning and drying instructions that can leave the scope channel wet.
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
- 1,025
- Deaths reported
- 6
- Injuries reported
- 36
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 1,025 adverse event reports that list this exact device (DI 04953170343360), received between Jun 28, 2018 and Sep 29, 2026 — classified as 6 deaths, 36 injuries, 983 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (519 reports).
4 FDA recall records name this device's identifier, 4 still open.
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 ↗
- Sep 18, 2024Class IIOpen, Classified
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Z-0498-2025 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
- Oct 2, 2023Class IIOpen, Classified
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Z-0288-2024 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately519
- Device Reprocessing Problem150
- Microbial Contamination of Device91
- Thermal Decomposition of Device47
- No Display/Image43
- Communication or Transmission Problem41
- Contamination41
- Poor Quality Image38
Patient problems
- No Clinical Signs, Symptoms or Conditions964
- Unspecified Infection10
- Drug Resistant Bacterial Infection9
- No Consequences Or Impact To Patient9
- Bacterial Infection8
- No Known Impact Or Consequence To Patient7
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 1,025 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936938 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924850 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
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 and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917065 ↗MalfunctionSep 24, 2026Break; Device Reprocessing Problem; Crack; Degraded; Electrical /Electronic Property Problem; Peeled/Delaminated; Gas/Air Leak; Scratched Material
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that white foreign objects were found on the air and water cylinder and tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888779 ↗MalfunctionSep 22, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861855 ↗MalfunctionSep 22, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861569 ↗MalfunctionSep 11, 2026Thermal Decomposition of Device
The customer reported that the Gastrointestinal Videoscope exhibited a burnt distal tip. It is unknown when the issue occurred. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742862 ↗MalfunctionSep 10, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723527 ↗MalfunctionSep 9, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699717 ↗MalfunctionSep 7, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50643712 ↗MalfunctionSep 2, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571593 ↗MalfunctionSep 1, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554115 ↗MalfunctionAug 28, 2026Device Reprocessing Problem; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495035 ↗MalfunctionAug 19, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325644 ↗MalfunctionJul 28, 2026Thermal Decomposition of Device
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated burn on the C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059678 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device; Failure to Clean Adequately
The customer returned the Gastrointestinal Videoscope, which is an Olympus asset with no reported complaint. During the evaluation of the device the repair center found the c-cover was burned, and the air/water tube and air/water cylinder had white foreign materials. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034044 ↗MalfunctionJul 17, 2026Thermal Decomposition of Device
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE DEVICE EXHIBITED A BURN INSIDE THE CHANNEL OPENING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863888 ↗MalfunctionJul 17, 2026Thermal Decomposition of Device; Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED WHITE FOREIGN MATERIAL WITHIN THE AIR/WATER TUBE AND CYLINDER. ADDITIONALLY, A BURNED PLASTIC DISTAL-END COVER WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862556 ↗MalfunctionJul 15, 2026Thermal Decomposition of Device
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR AN EVALUATION OF A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A BURNED C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25828961 ↗MalfunctionJul 9, 2026Device Reprocessing Problem; Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED FOREIGN OBJECTS IN THE JET TUBE AND A NOISY IMAGE DUE TO A DAMAGED CHARGED COUPLED DEVICE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762067 ↗MalfunctionJul 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE DEVICE EXHIBITED FOREIGN OBJECTS WITHIN THE AIR/WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25756409 ↗MalfunctionJul 8, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD WHITE FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25747166 ↗MalfunctionJul 6, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER WITH NO REPORTED COMPLAINT. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN MATERIAL IN THE AUXILIARY WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719412 ↗MalfunctionJul 3, 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 FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703872 ↗MalfunctionJul 2, 2026Failure to Clean Adequately
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD BLACK FLUID COMING OUT OF THE DISTAL TIP. THE ISSUE OCCURRED AFTER REPROCESSING WHILE THE SCOPE WAS HUNG UP TO DRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25693118 ↗
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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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