EVIS EXERA II SMALL INTESTINAL VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 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 SMALL INTESTINAL VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 195
- Deaths reported
- 2
- Injuries reported
- 39
- Recalls
- 1
We found 4 models of EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2018 and Sep 28, 2026 — classified as 2 deaths, 39 injuries, 154 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (69 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 SMALL INTESTINAL 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-0343-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE problems
Device problems
- Failure to Clean Adequately69
- Adverse Event Without Identified Device or Use Problem39
- Microbial Contamination of Device32
- No Display/Image12
- Device Reprocessing Problem7
- Contamination5
- Residue After Decontamination5
- Melted4
Patient problems
- No Clinical Signs, Symptoms or Conditions145
- Hemorrhage/Blood Loss/Bleeding11
- Perforation9
- Abdominal Pain7
- Pancreatitis7
- Hypoxia6
- Laceration(s) of Esophagus6
- No Known Impact Or Consequence To Patient6
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180Enteroscope and accessories1 death96 reports
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180endoscopic access overtube, gastroenterology-urology1 recall42 reports
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180Enteroscope and accessories51 reports
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180Endoscope, accessories, narrow band spectrum1 death6 reports
Recent EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Erratic or Intermittent Display; No Display/Image
The customer reported the small intestinal videoscope had no image during reprocessing. During the initial evaluation of the device it was observed, intermit/flicker Image. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922029 ↗MalfunctionSep 22, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862918 ↗MalfunctionSep 21, 2026No Display/Image
The customer reported no image during Maintenance involving an Olympus small intestinal videoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846189 ↗MalfunctionSep 10, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724597 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, a foreign material was found in the nozzle. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671892 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for a separate issue. During device analysis, the service center identified foreign objects in the air/water tube and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670267 ↗MalfunctionAug 31, 2026Contamination
The customer reported that the small intestinal videoscope had a biodurden stuck inside the unit. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50526205 ↗MalfunctionAug 26, 2026Poor Quality Image; Residue After Decontamination
The customer returned the Small Intestinal Videoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicated that a foreign object was found in the nozzle and that the image was disturbed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50447032 ↗MalfunctionAug 25, 2026Thermal Decomposition of Device
The customer reported that the Small Intestinal Videoscope had a separate issue. During the initial evaluation, burn marks were observed on the distal-end plastic. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430336 ↗MalfunctionAug 10, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50199419 ↗MalfunctionAug 7, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175606 ↗MalfunctionJul 29, 2026Device Reprocessing Problem
The customer returned the Intestinal videoscope to the service center for a separate issue. During the device analysis, the service repair technician observed that the device had foreign objects within the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075201 ↗MalfunctionJul 27, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005960 ↗MalfunctionJul 21, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR CENTER IDENTIFIED WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25895029 ↗MalfunctionJul 7, 2026Mechanical Jam
THE CUSTOMER REPORTED A CLIP JAMMED IN THE INSTRUMENT CHANNEL DURING PRE-USE INSPECTION OF AN OLYMPUS SMALL INTESTINAL VIDEOSCOPE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25739029 ↗
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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