EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 (UDI 04953170202285)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II is a gastrointestinal videoscope. Many of the 135 reports describe the scope not being cleaned adequately or being contaminated with microbes, and some describe blurry or noisy images. There are no deaths and 11 injuries, and reports rose from 9 in the previous 12 months to 26 in the latest 12 months. 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
- 134
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 04953170202285), received between May 15, 2018 and Aug 25, 2026 — classified as 11 injuries, 123 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (45 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 Adequately45
- Microbial Contamination of Device44
- Poor Quality Image12
- Adverse Event Without Identified Device or Use Problem11
- Device Reprocessing Problem8
- Corroded5
- Erratic or Intermittent Display4
- No Display/Image4
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Known Impact Or Consequence To Patient22
- Injury9
- No Consequences Or Impact To Patient9
- Laceration(s)1
- Perforation1
- Pulmonary Embolism1
Recent adverse event reports
The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Failure to Clean Adequately
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422530 ↗MalfunctionJun 23, 2026Corroded
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, CORROSION ON THE LIGHT GUIDE LENS WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593252 ↗MalfunctionMay 27, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH SEPARATE CASE. DURING THE EVALUATION OF THE DEVICE, BLURRY IMAGE WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE BLURRY IMAGE WAS DUE TO POLISHED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300723 ↗MalfunctionMay 20, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233841 ↗MalfunctionMay 20, 2026Poor Quality Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE PRODUCED A BLURRY IMAGE. THE ISSUE WAS FOUND DURING PRE-USE INSPECTION AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231989 ↗MalfunctionMay 15, 2026Corroded
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF MISALIGNMENT OF ANGLES AND PLAY IN THE KNOBS, DURING PREVENTIVE MAINTENANCE; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE NOZZLE WAS CORRODED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184136 ↗MalfunctionMay 13, 2026No Display/Image
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF PROBLEM WITH THE IMAGE; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159273 ↗MalfunctionMay 12, 2026Erratic or Intermittent Display; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD THE UNIVERSAL CORD BE STICKY AND THE IMAGE HAD LINEAR SCRATCHES CAUSING A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150497 ↗MalfunctionApr 8, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CORROSION ON NOZZLE AND DIRTY ELECTRONIC CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815679 ↗MalfunctionApr 6, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792802 ↗MalfunctionApr 2, 2026No Display/Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766702 ↗MalfunctionMar 30, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE PRESENTED STICKY UNIVERSAL CORD AND SCOPE COVER UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717702 ↗MalfunctionMar 24, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE C-COVER OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675422 ↗MalfunctionMar 20, 2026Poor Quality Image
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD IMAGE INTERFERENCE. THERE WAS NOISE IN THE IMAGE AND THE IMAGE RECORDED ON ITS OWN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649272 ↗MalfunctionMar 16, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CORROSION IN THE AIR/WATER COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603216 ↗MalfunctionMar 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A STICKY CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592354 ↗MalfunctionMar 2, 2026Corroded; No Display/Image
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A CORRODED PLASTIC DISTAL END COVER AND DID NOT PRODUCE AN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24485598 ↗MalfunctionFeb 26, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD IMAGE INTERFERENCE OR NOISINESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456149 ↗MalfunctionFeb 13, 2026Erratic or Intermittent Display
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD IMAGE INTERFERENCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335698 ↗MalfunctionFeb 4, 2026Device Reprocessing Problem; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258824 ↗MalfunctionJan 21, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134383 ↗MalfunctionJan 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD FIBROUS FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004481 ↗MalfunctionJan 2, 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 23943981 ↗MalfunctionDec 30, 2025Poor Quality Image; Poor Quality Image
NO NEW INFORMATION RECEIVED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926860 ↗MalfunctionDec 18, 2025Failure to Clean Adequately; Failure to Clean Adequately
NO NEW INFORMATION RECEIVED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838130 ↗
Other Colonoscope and accessories, flexible/rigid devices
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- 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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