EVIS EXERA SIGMOIDOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 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 SIGMOIDOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of EVIS EXERA SIGMOIDOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2021 and Jul 29, 2026 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (9 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 SIGMOIDOVIDEOSCOPE 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 · Recall details · FDA record ↗
Most reported EVIS EXERA SIGMOIDOVIDEOSCOPE problems
Device problems
- No Display/Image9
- Device Reprocessing Problem7
- Failure to Clean Adequately5
- Residue After Decontamination5
- Corroded3
- Poor Quality Image2
- Adverse Event Without Identified Device or Use Problem1
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
- Low Oxygen Saturation1
- Pancreatitis1
- Pneumonia1
EVIS EXERA SIGMOIDOVIDEOSCOPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160SEndoscopic video imaging system/component, gastroenterology-urology1 recall1 report
- EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160SEndoscopic video imaging system/component, gastroenterology-urology19 reports
- EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160SEndoscopic video imaging system/component, gastroenterology-urology13 reports
Recent EVIS EXERA SIGMOIDOVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065964 ↗MalfunctionJul 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057091 ↗MalfunctionJul 27, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50043270 ↗MalfunctionJun 12, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE SIGMOIDOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD DARK DEBRIS IN LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488451 ↗MalfunctionJun 8, 2026Corroded
THE CUSTOMER RETURNED THE SIGMOIDOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD CORROSION ON NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432763 ↗MalfunctionMay 12, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN AIR-WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148039 ↗MalfunctionApr 8, 2026Corroded; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD FOREIGN MATERIAL PRESENT IN THE NOZZLE AND EXHIBITED NOZZLE CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818476 ↗MalfunctionApr 1, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD CORROSION ON NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756570 ↗MalfunctionMar 17, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD A FOREIGN MATER AT THE AIR WATER CHANNEL AND TUBE OF THE CONTROL UNIT AND AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615178 ↗MalfunctionFeb 25, 2026Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SIGMOIDOVIDEOSCOPE TESTED POSITIVE FOR >50 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA, 18 COLONY FORMING UNITS (CFUS) OF ACINETOBACTER SPECIES, AND 2 COLONY FORMING UNITS (CFUS) OF GRAM-NEGATIVE ROD. 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 24444814 ↗MalfunctionFeb 17, 2026Failure to Clean Adequately
IT WAS REPORTED THAT THE SIGMOIDOVIDEOSCOPE HAD LEAKAGE OF BLACK LIQUID. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369995 ↗MalfunctionJan 28, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD BLACK FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24204562 ↗MalfunctionJan 28, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED GRAINY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24204301 ↗MalfunctionJan 28, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203489 ↗MalfunctionJan 2, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED WHITE RESIDUE IN THE COVER GLASS AND LIGHT GUIDE ROD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946278 ↗
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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