EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190 (REF N3803041)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
Quick summary
This Olympus EVIS EXERA III videoscope is a flexible scope used to look inside the digestive tract. Many of the 178 reports describe the scope not cleaning adequately, and some describe no image, blurry images or jammed forceps. The reports include 174 malfunctions, 3 injuries and 1 death. Reports from the last 12 months number 21, compared with 8 in the 12 months before. No recalls name this device.
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
- 178
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 04953170436758), received between Jun 19, 2023 and Sep 24, 2026 — classified as 1 death, 3 injuries, 174 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (118 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.
Reports received per month
Most reported problems
Device problems
- Failure to Clean Adequately118
- Device Reprocessing Problem17
- Poor Quality Image10
- No Display/Image8
- Communication or Transmission Problem6
- Microbial Contamination of Device6
- Erratic or Intermittent Display5
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions174
- Bacterial Infection2
- Hemorrhage/Blood Loss/Bleeding2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pleural Effusion1
Recent adverse event reports
The 25 most recent of 178 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891874 ↗MalfunctionSep 22, 2026Erratic or Intermittent Display
The customer reported that during an inspection for use, the Gastrointestinal Videoscope displayed artifacts in the image (colored snow). No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849708 ↗MalfunctionJul 7, 2026Erratic or Intermittent Display; Residue After Decontamination
THE CUSTOMER REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A VERTICAL LINE IN THE IMAGE. IN ADDITION, RESIDUE BUILDUP WAS OBSERVED ON THE CHARGED COUPLED DEVICE UNIT (CCD). IT IS UNKNOWN WHEN THE ISSUE OCCURRED AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738536 ↗MalfunctionJun 11, 2026Poor Quality Image
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 A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476439 ↗MalfunctionJun 1, 2026Poor Quality Image
THE CUSTOMER REPORTED VISUAL INTERFERENCE, WITH THE APPEARANCE OF LINES ON THE SCREEN DURING UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351944 ↗MalfunctionJun 1, 2026Communication or Transmission Problem
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE DISPLAYED ERROR CODE E237 DURING A THERAPEUTIC ENDOSCOPY. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351089 ↗MalfunctionMay 27, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED IMAGE INTERFERENCE DURING SERVICE MAINTENANCE INVOLVING AN GASTROINTESTINAL VIDEOSCOPE THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299575 ↗MalfunctionMay 13, 2026Mechanical Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE FORCEPS WERE JAMMED. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159984 ↗MalfunctionApr 7, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800541 ↗MalfunctionMar 31, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED DIRT ON THE OBJECTIVE LENS, CAUSING A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742118 ↗MalfunctionMar 24, 2026Erratic or Intermittent Display; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673772 ↗MalfunctionMar 23, 2026Communication or Transmission Problem
IT WAS REPORTED THAT GASTROINTESTINAL VIDEOSCOPE HAD E238 ENDOSCOPE ERROR. THE ISSUE HAD OCCURRED DURING INSPECTION FOR USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669994 ↗MalfunctionMar 5, 2026No Display/Image; Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE IMAGE DID NOT DISPLAY, AND A BLACK IMAGE APPEARED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520930 ↗MalfunctionFeb 27, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471522 ↗MalfunctionFeb 23, 2026No Display/Image; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415888 ↗MalfunctionJan 30, 2026Communication or Transmission Problem
IT WAS REPORTED THAT GASTROINTESTINAL VIDEOSCOPE HAD A B30 SCOPE COMMUNICATION ERROR. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221706 ↗MalfunctionJan 7, 2026Erratic or Intermittent Display
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS INTERMITTENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990572 ↗MalfunctionJan 6, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23978301 ↗MalfunctionDec 30, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A NO IMAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930776 ↗MalfunctionDec 18, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD RESIDUE ON THE LIGHT LENSES. THE ISSUE WAS FOUND DURING DEVICE SET UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838163 ↗MalfunctionNov 4, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467826 ↗MalfunctionFeb 26, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE LIGHT GUIDE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21474542 ↗MalfunctionFeb 20, 2025Contamination; Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD FOREIGN MATERIAL ON THE OBJECTIVE AND LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425773 ↗InjuryJan 2, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED VIA MEDWATCH REPORT THAT THE SUBJECT VIDEOSCOPE WAS SUSPECTED TO BE INVOLVED IN A SALMONELLA INFECTION TO A PATIENT. THE REPORT ALSO INDICATED THE PATIENT WAS HOSPITALIZED. NO FURTHER INFORMATION WAS OBTAINED.
Patient problems: Bacterial Infection
MAUDE report 21057393 ↗InjuryJan 2, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED VIA MEDWATCH REPORT THAT THE SUBJECT VIDEOSCOPE WAS SUSPECTED TO BE INVOLVED IN A SALMONELLA INFECTION TO A PATIENT. THE REPORT ALSO INDICATED THE PATIENT WAS HOSPITALIZED. NO FURTHER INFORMATION WAS OBTAINED.
Patient problems: Bacterial Infection
MAUDE report 21057371 ↗
Other Colonoscope And Accessories, Flexible/Rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
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
- 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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