EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190 (REF N3802941)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 video scope is a flexible scope used to look inside the digestive tract. Its 331 reports mostly describe scopes not being cleaned adequately, germ contamination and poor or missing images. The reports mention no deaths and 8 injuries. No recalls name this device. Reports rose from 13 in the prior 12 months to 54 in the latest 12 months.
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
- 325
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 325 adverse event reports that list this exact device (DI 04953170436734), received between Dec 9, 2022 and Sep 29, 2026 — classified as 8 injuries, 317 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (140 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 Adequately140
- Microbial Contamination of Device98
- Poor Quality Image22
- Device Reprocessing Problem18
- No Display/Image18
- Corroded8
- Thermal Decomposition of Device8
- Communication or Transmission Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions317
- Bacterial Infection5
- Viral Infection4
- Abdominal Pain2
- Hemorrhage/Blood Loss/Bleeding2
- Fever1
- Fungal Infection1
- Perforation1
Recent adverse event reports
The 25 most recent of 325 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Communication or Transmission Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the device, there was an E217 error (scope error). There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933142 ↗MalfunctionSep 21, 2026Failure to Clean Adequately
The customer reported dirty objective and light lenses and a dirty light guide cap during a functional check involving an Olympus Gastrointestinal Videoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847131 ↗MalfunctionJul 9, 2026Electrical /Electronic Property Problem; Melted; Gas/Air Leak; Positioning Problem; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN ON THE TERMINAL COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770873 ↗MalfunctionJul 9, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL IN THE AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766554 ↗MalfunctionJul 8, 2026Corroded; Crack; Degraded; No Display/Image; Positioning Problem
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25756561 ↗MalfunctionJul 2, 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 BIOPSY CHANNEL HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690244 ↗MalfunctionJun 17, 2026Poor Quality Image; Failure 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 A BLURRY IMAGE AND FOREIGN MATERIAL ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535916 ↗MalfunctionJun 16, 2026Corroded
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 CORROSION ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526878 ↗MalfunctionJun 16, 2026No Display/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 NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526867 ↗MalfunctionJun 11, 2026Corroded
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE SUCTION CHAMBER HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476579 ↗MalfunctionJun 1, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE DISPLAYED AN E315 UNSUPPORTED SCOPE ERROR MESSAGE. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350444 ↗MalfunctionMay 28, 2026No 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 25318992 ↗MalfunctionMay 26, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD DIRT ON THE OBJECTIVE LENS CAUSING IMAGE ISSUES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285596 ↗MalfunctionMay 18, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE PRODUCED A SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202728 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED DIRTY OBJECTIVE AND LIGHT GUIDE LENSES. IT IS UNKNOWN WHEN THIS ISSUE WAS FOUND. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148894 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002305 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS BLURRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002094 ↗MalfunctionApr 17, 2026No 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 24913383 ↗MalfunctionApr 7, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE OBJECTIVE LENS OF THE GASTROINTESTINAL VIDEOSCOPE HAD DIRT ON IT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799947 ↗MalfunctionApr 7, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE SMALL LID WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799543 ↗MalfunctionApr 3, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECT IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779746 ↗MalfunctionMar 31, 2026Erratic or Intermittent Display; No Display/Image
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A NOISY IMAGE AND THEN NO IMAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746460 ↗MalfunctionMar 30, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716151 ↗MalfunctionMar 18, 2026Corroded
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A CORRODED INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627717 ↗MalfunctionMar 16, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A BLURRED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607713 ↗
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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