EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180 (UDI 04953170237423)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus small intestinal videoscope (SIF type Q180) is a thin flexible scope used to look inside the small intestine. Its 50 reports mostly describe cleaning problems and contamination found during service testing, along with a few image quality and overheating issues; one report describes a perforation, with no deaths and one injury. No recalls name this device. Reports in the last 12 months (13) are higher than the prior 12 months (4).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04953170237423), received between Oct 9, 2018 and Sep 8, 2026 — classified as 1 injury, 50 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (27 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Clean Adequately27
- Microbial Contamination of Device14
- Contamination2
- Poor Quality Image2
- Adverse Event Without Identified Device or Use Problem1
- Device Reprocessing Problem1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Perforation1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗MalfunctionJun 23, 2026Failure to Clean Adequately
THE OLYMPUS SMALL INTESTINAL VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A SEPARATE ISSUE. HOWEVER, A REPORTABLE MEDICAL DEVICE FAILURE WAS IDENTIFIED DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FOREIGN OBJECT WAS FOUND IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25595827 ↗MalfunctionMay 28, 2026Poor Quality Image
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD IMAGE ROUGHNESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321176 ↗MalfunctionMay 20, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD BURNT C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25228846 ↗MalfunctionMar 16, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE WAS NOT PRODUCING AN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607597 ↗MalfunctionMar 12, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, SMALL INTESTINAL VIDEOSCOPE NOZZLE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579082 ↗MalfunctionFeb 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED AIR WATER TUBE AND CYLINDER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338612 ↗MalfunctionJan 30, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD A GRAINY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228299 ↗MalfunctionJan 19, 2026Material Integrity Problem
IT WAS REPORTED THE SMALL ITESTINAL VIDEOSCOPE EXHIBITED DIRT ON THE OUTER CASING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112305 ↗MalfunctionJan 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS CLOGGING THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053740 ↗MalfunctionDec 18, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843164 ↗MalfunctionDec 4, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SMALL INTESTINAL VIDEOSCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE SS. PNEUMONIAE. THE DEVICE WAS RETESTED ON (B)(6) 2025, AND IT TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE SS. PNEUMONIAE. THE DEVICE WAS TESTED AGAIN ON (B)(6) 2025, AND TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE SS. PNEUMONIAE IN THE BIOPSY CHANNEL. THE DEVICE WAS TESTED AGAIN ON (B)(6) 2025, AND TESTED POSITIVE FOR ESCHERICHIA COLI. 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 23719756 ↗MalfunctionJun 6, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE SMALL INTESTINAL VIDEOSCOPE SWITCH 1 WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157973 ↗MalfunctionMay 22, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072569 ↗MalfunctionMay 19, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINE VIDEOSCOPE EXHIBITED FOREIGN OBJECTS CAME OUT OF THE DISTAL END DUE TO A CLOGGED NOZZLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045959 ↗MalfunctionFeb 24, 2025Material Deformation; Material Deformation
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED A BURNED PROBE COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446182 ↗MalfunctionAug 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED ADHESIVE AROUND LIGHT GUIDE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20048598 ↗MalfunctionAug 14, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED A WHITISH FOREIGN MATERIAL WAS FOUND INSIDE THE AIR/WATER TUBE AND THE AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983151 ↗MalfunctionJun 24, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE SMALL INTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. 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 19599745 ↗MalfunctionJun 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19585696 ↗MalfunctionJun 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE FLEX VIDEO SCOPE NOZZLE, AIR/WATER TUBE AND AIR/WATER CYLINDER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581560 ↗MalfunctionMar 28, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE SMALL INTESTINAL VIDEOSCOPE AIR/WATER TUBE AND AIR/WATER CYLINDER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993313 ↗MalfunctionJan 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
A USER FACILITY RETURNED THE OLYMPUS DEVICE, SMALL INTESTINAL VIDEOSCOPE, TO THE OLYMPUS REGIONAL REPAIR CENTER FOR SERVICE/REPAIR. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT AIR WATER CYLINDER AND TUBE HAD FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18521646 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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