EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165 (UDI 04953170339806)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 videoscope is a flexible endoscope used to look inside the stomach and intestines. Its 155 reports mostly describe trouble cleaning the scope between uses, blurry images, and germs found on the device, and many say no patient was involved. The reports include no deaths and no injuries. Reports rose from 28 in the year before to 57 in the latest year.
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
- 154
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 04953170339806), received between Aug 16, 2018 and Sep 28, 2026 — classified as 154 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (59 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 Adequately59
- Microbial Contamination of Device23
- Poor Quality Image23
- Device Reprocessing Problem22
- Corroded6
- No Display/Image6
- Contamination4
- Erratic or Intermittent Display4
Patient problems
- No Clinical Signs, Symptoms or Conditions141
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
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 foreign material on the light guide lens and foreign material in the air/water cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917024 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer reported the Gastrointestinal Videoscope had a separate issue. During the initial evaluation of the device it was observed that, the light guide lens has foreign objects. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898088 ↗MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861731 ↗MalfunctionSep 3, 2026Misfocusing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50586603 ↗MalfunctionAug 17, 2026Poor Quality Image
The customer returned the Gastrointestinal Videoscope for a separate issue. During inspection of the device, it was found that the image was blurry. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277825 ↗MalfunctionJul 3, 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 LIGHT GUIDE LENS AND INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704854 ↗MalfunctionJun 29, 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 LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652523 ↗MalfunctionJun 29, 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 ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652493 ↗MalfunctionJun 23, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING THE REPAIR CENTER TECHNICIAN FOUND FOREIGN MATERIAL ON THE AIR WATER CHANNEL AND AIR WATER PISTON CAGE, CAUSE NOT IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598803 ↗MalfunctionJun 5, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING EVALUATION OF THE DEVICE, FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND THE AIR/WATER TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407936 ↗MalfunctionJun 2, 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 LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361630 ↗MalfunctionJun 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE EVALUATION, THE DEVICE WAS OBSERVED TO HAVE FOREIGN MATERIAL IN THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354339 ↗MalfunctionMay 26, 2026Poor Quality Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD BLURRY IMAGES. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25287218 ↗MalfunctionMay 26, 2026Poor Quality Image
THE CUSTOMER REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLURRY IMAGE. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279783 ↗MalfunctionMay 26, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279553 ↗MalfunctionMay 24, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED LIGHT GUIDE COVER LENS (SMALL) HAD FOREIGN MATERIAL AND AIR/WATER CYLINDER HAD FOREIGN BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266837 ↗MalfunctionMay 20, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS PRESENT IN THE AIR-WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232805 ↗MalfunctionMay 15, 2026Device Reprocessing Problem
AN OLYMPUS FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING AN ONSITE INSPECTION OF THE GASTROINTESTINAL VIDEOSCOPE THE PLASTIC DISTAL END COVER RESISTANCE WAS BELOW STANDARD, GRAY, CRACKED ADHESIVES AROUND THE LENSES, NON-ORIGINAL PROBE ARMOR AND BENDING SECTION COVER. THIS DOES NOT INDICATE A MEDICAL DEVICE REPORTABLE (MDR) EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE AT THE SERVICE CENTER, THE ELECTRICAL CONNECTOR WAS FOUND TO BE DIRTY, MOST LIKELY DUE TO WATER LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25189363 ↗MalfunctionMay 15, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD AN INTERMITTENT IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25187564 ↗MalfunctionMay 14, 2026Corroded
THE INITIAL CUSTOMER ALLEGATION WAS FOUND TO BE NON-REPORTABLE. IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT GUIDE LENS HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178552 ↗MalfunctionMay 14, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176871 ↗MalfunctionMay 13, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF "AIR INSUFFLATION MALFUNCTION". THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, DURING INSPECTION OF THE DEVICE AT THE SERVICE CENTER, AN MDR REPORTABLE MALFUNCTION WAS NOTED IN WHERE FOREIGN OBJECTS WERE FOUND ON THE FORCEPS CHANNEL PORT, AIR/WATER CYLINDER, SUCTION CYLINDER, C-COVER, AND NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166733 ↗MalfunctionMay 13, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE LIGHT GUIDE LENS HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158582 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152246 ↗MalfunctionMay 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL IN THE LIGHT GUIDE COVER LENS OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128888 ↗
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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
- 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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