EVIS EXERA GASTROINTESTINAL VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 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 GASTROINTESTINAL VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 5 models of EVIS EXERA GASTROINTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Jun 8, 2026 — classified as 2 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (24 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 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 3 of these models · Recall details · FDA record ↗
Most reported EVIS EXERA GASTROINTESTINAL VIDEOSCOPE problems
Device problems
- Failure to Clean Adequately24
- Microbial Contamination of Device15
- Device Reprocessing Problem12
- Poor Quality Image8
- Contamination4
- Residue After Decontamination3
- Adverse Event Without Identified Device or Use Problem2
- Erratic or Intermittent Display2
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Hemorrhage/Blood Loss/Bleeding2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
- No Patient Involvement1
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XTQ160Gastroscope and accessories, flexible/rigid1 recall30 reports
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q160ZGastroscope and accessories, flexible/rigid1 recall4 reports
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2T160Endoscopic video imaging system/component, gastroenterology-urology1 recall3 reports
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2T160Endoscopic video imaging system/component, gastroenterology-urology32 reports
- EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XTQ160Gastroscope and accessories, flexible/rigid2 reports
Recent EVIS EXERA GASTROINTESTINAL VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 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 IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434067 ↗MalfunctionMay 13, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF FAILED LEAK TEST THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THERE WERE FOREIGN MATERIALS COMING OUT OF THE DISTAL END OF THE GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162465 ↗MalfunctionMay 5, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD BLACK FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084546 ↗MalfunctionApr 17, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910139 ↗MalfunctionApr 9, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827296 ↗MalfunctionMar 12, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A RED SUBSTANCE ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578828 ↗MalfunctionFeb 6, 2026Microbial Contamination of Device
IT WAS REPORTED THAT DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR >100 COLONY FORMING UNITS (CFU) OF CITROBACTER FREUNDII, GRAM-NEGATIVE BACILLI OF THE ENTEROBACTERIACEAE FAMILY, AND MOLDS. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281608 ↗MalfunctionJan 22, 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 24151446 ↗MalfunctionDec 29, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918837 ↗MalfunctionDec 23, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882753 ↗MalfunctionDec 12, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CHEMICAL RESIDUE IN THE AUXILIARY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23791144 ↗MalfunctionDec 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE OBJECT STUCK INSIDE THE SCOPE, THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769610 ↗MalfunctionDec 9, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROVIDEOSCOPE IMAGE-EVIS EXHIBITED INTERMIT/FLICKER IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23753217 ↗MalfunctionDec 8, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752574 ↗MalfunctionDec 2, 2025Erratic or Intermittent Display; Poor Quality Image; Erratic or Intermittent Display; Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLURRY AND FLICKERING IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697583 ↗
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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