EVIS EXERA II GASTROINTESTINAL VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 20 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,267
- Deaths reported
- 1
- Injuries reported
- 39
- Recalls
- 1
We found 20 models of EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 2,267 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2017 and Sep 30, 2026 — classified as 1 death, 39 injuries, 2,227 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (767 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 6 of these models · Recall details · FDA record ↗
Most reported EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE problems
Device problems
- Failure to Clean Adequately767
- Poor Quality Image332
- Microbial Contamination of Device324
- Device Reprocessing Problem272
- No Display/Image201
- Erratic or Intermittent Display86
- Contamination59
- Corroded52
Patient problems
- No Clinical Signs, Symptoms or Conditions2,016
- No Known Impact Or Consequence To Patient118
- No Consequences Or Impact To Patient75
- No Patient Involvement17
- Injury9
- Insufficient Information9
- Perforation8
- Hemorrhage/Blood Loss/Bleeding7
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Gastroscope and accessories, flexible/rigid349 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Gastroscope and accessories, flexible/rigid1 death302 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180Endoscope, accessories, narrow band spectrum286 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180JEndoscope, accessories, narrow band spectrum1 recall202 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180JColonoscope and accessories, flexible/rigid231 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Gastroscope and accessories, flexible/rigid154 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180Gastroscope and accessories, flexible/rigid137 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Colonoscope and accessories, flexible/rigid134 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180Gastroscope and accessories, flexible/rigid1 recall76 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180Colonoscope and accessories, flexible/rigid1 recall64 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180JEndoscope, accessories, narrow band spectrum86 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180Gastroscope and accessories, flexible/rigid1 recall32 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Colonoscope and accessories, flexible/rigid1 recall30 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180NEndoscope, accessories, narrow band spectrum1 recall12 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180JGastroscope and accessories, flexible/rigid59 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180NEndoscope, accessories, narrow band spectrum35 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180Endoscope, accessories, narrow band spectrum24 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180Gastroscope and accessories, flexible/rigid24 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180NColonoscope and accessories, flexible/rigid20 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180Endoscope, accessories, narrow band spectrum10 reports
Recent EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954041 ↗MalfunctionSep 30, 2026Mechanical Jam
The customer reported that the angulation knob was stuck and would not move during an unspecified procedure involving an Olympus Gastrointestinal Videoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951217 ↗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 28, 2026Failure to Clean Adequately
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the returned device, foreign materials were observed on the air/water tube and air/water cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917632 ↗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 28, 2026Erratic or Intermittent Display
It was reported that the Gastrointestinal Videoscope had image interference. There were no reports of patient harm or injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913986 ↗MalfunctionSep 28, 2026No Display/Image; Poor Quality Image
It was reported that the Gastrointestinal Videoscope had a fuzzy image. Changing the cable did not resolve the issue. The image eventually disappeared and did not return. The issue occurred during device setup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913628 ↗MalfunctionSep 25, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal videoscope to the service center for evaluation related to a separate issue. During the initial device analysis, unknown foreign material was observed within the nozzle. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898450 ↗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 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 ↗MalfunctionSep 24, 2026Poor Quality Image
It was reported that during a diagnostic Upper Gastrointestinal procedure (UGD) with use of the gastrointestinal videoscope, the screen would not work. The customer reported that the image was distorted and the freeze control button was not working. The procedure was completed with the same device. There was no report of patient injury or adverse patient effects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884394 ↗MalfunctionSep 23, 2026Melted
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865920 ↗MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861731 ↗MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861667 ↗MalfunctionSep 22, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860452 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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