EVIS EXERA COLONOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EVIS EXERA COLONOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of EVIS EXERA COLONOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2022 and Jun 16, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (2 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 COLONOVIDEOSCOPE 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, 2023Open, 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-0329-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported EVIS EXERA COLONOVIDEOSCOPE problems
Device problems
- Failure to Clean Adequately2
- Device Reprocessing Problem1
- Microbial Contamination of Device1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
EVIS EXERA COLONOVIDEOSCOPE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE 2T160IEndoscopic video imaging system/component, gastroenterology-urology1 recall1 report
- EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE 2T160LEndoscopic video imaging system/component, gastroenterology-urology1 recall0 reports
- EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE 2T160LEndoscopic video imaging system/component, gastroenterology-urology2 reports
- EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE Q160ZLColonoscope and accessories, flexible/rigid1 report
- EVIS EXERA COLONOVIDEOSCOPE OLYMPUS CF TYPE 2T160LEndoscopic video imaging system/component, gastroenterology-urology1 report
Recent EVIS EXERA COLONOVIDEOSCOPE adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT WHITE FOREIGN OBJECT IN AIR WATER TUBE AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522241 ↗MalfunctionFeb 2, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233852 ↗MalfunctionJan 18, 2024Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO OLYMPUS, THAT THE OLYMPUS ENDOSCOPE REPROCESSOR (OER) WAS USED TO IMPROPERLY REPROCESS THE COLONOVIDEOSCOPE WITH AN EXPIRED WATER FILTER. THE WATER FILTER HAD NOT BEEN CHANGED SINCE 2021, SUBSEQUENTLY LEADING TO THE MISMANAGEMENT OF REPLACING THE WATER FILTER IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THERE WERE NO REPORTS OF PATIENT HARM, INJURY, OR INFECTION. RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18538390 ↗MalfunctionJul 12, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE EVIS EXERA COLONOVIDEOSCOPE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR ANNUAL MAINTENANCE WITH NO COMPLAINT REPORTED BY THE END USER. DURING INSPECTION, IT WAS DISCOVERED THERE WAS FOREIGN MATTER FOUND WITHIN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17307834 ↗MalfunctionFeb 23, 2022Microbial Contamination of Device; Microbial Contamination of Device
AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13589153 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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