EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 (UDI 04953170339769)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus GIF-H180 colonoscope is a flexible endoscope used to look inside the digestive tract. The 30 reports mostly describe cleaning problems and video issues, such as image loss or flickering, plus a few parts melting or overheating, with no deaths or injuries and no reported harm to patients. One recall, open since September 2023, involves scopes returning from repair with water left inside the air channel, which can allow contamination and infection. Reports rose from 7 to 17 in the last 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04953170339769), received between Dec 5, 2020 and Sep 28, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (8 reports).
1 FDA recall record name this device's identifier, 1 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
- 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 Adequately8
- Erratic or Intermittent Display5
- No Display/Image5
- Poor Quality Image5
- Melted2
- Overheating of Device2
- Residue After Decontamination2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Poor Quality Image
The customer returned the gastrointestinal videoscope for a separate issue. During the initial evaluation, a noisy image was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923426 ↗MalfunctionSep 24, 2026No Display/Image; Display or Visual Feedback Problem; Poor Quality Image
It was reported the Gastrointestinal Videoscope exhibited a flickering and no image issue. The issue occurred during reprocessing. There was no patient involvement. The device was returned to Olympus. During the device analysis, a noisy image was found due to damage on the charged coupled device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886563 ↗MalfunctionJul 27, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038634 ↗MalfunctionMay 29, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25339935 ↗MalfunctionApr 15, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE SCOPE CONNECTOR COVER OF THE GASTROINTESTINAL VIDEOSCOPE WAS STICKY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885806 ↗MalfunctionMar 9, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE SWITCH 4 WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550219 ↗MalfunctionMar 5, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE'S IMAGE GUIDE PROTECTOR WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520928 ↗MalfunctionFeb 17, 2026Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366283 ↗MalfunctionFeb 13, 2026No Display/Image; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE SUCTION CYLINDER AND A NO IMAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332560 ↗MalfunctionFeb 2, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24239753 ↗MalfunctionJan 27, 2026Melted
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189171 ↗MalfunctionJan 21, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE IMAGE WAS DISTURBED WHEN THE CONNECTOR WAS PUSHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131751 ↗MalfunctionJan 16, 2026Erratic or Intermittent Display; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE SUCTION CYLINDER AND NOISE ON THE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095385 ↗MalfunctionJan 13, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BURNT C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054804 ↗MalfunctionJan 6, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED AN IMAGE NOISE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23978829 ↗MalfunctionJan 2, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE ON MONITOR. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945063 ↗MalfunctionDec 10, 2025No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXPERIENCED A NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770063 ↗MalfunctionOct 27, 2025Erratic or Intermittent Display; Poor Quality Image; Erratic or Intermittent Display; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391940 ↗MalfunctionSep 2, 2025Flare or Flash; Flare or Flash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937260 ↗MalfunctionAug 15, 2025Overheating of Device; Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE'S PROBE COVER WAS FOUND BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816135 ↗MalfunctionJun 27, 2025Misfocusing; Misfocusing
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343896 ↗MalfunctionJun 20, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN OBJECTS IN THE SUCTION-CYLINDER (S-CYLINDER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301045 ↗MalfunctionJun 20, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297651 ↗MalfunctionJun 17, 2025Melted; Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BURN ON THE CAMERA COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235749 ↗MalfunctionMay 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN THE AIR/WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19338215 ↗
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 · 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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