EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180 (UDI 04953170339936)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus small intestinal videoscope is a camera scope used to look inside the small intestine. The 42 reports mostly describe cleaning problems, with contamination or leftover material found in the air and water channels during checks, with no patient involvement mentioned in recent reports. There were no deaths and 3 injuries. There is 1 open recall started in September 2023 about scopes returned after repair with wet channels that could carry infection risk.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04953170339936), received between Nov 6, 2018 and Sep 10, 2026 — classified as 3 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (16 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- 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 problems
Device problems
- Failure to Clean Adequately16
- Microbial Contamination of Device14
- Device Reprocessing Problem3
- Adverse Event Without Identified Device or Use Problem2
- Overheating of Device2
- Residue After Decontamination2
- Contamination1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Known Impact Or Consequence To Patient3
- Abdominal Pain2
- Nausea2
- Pancreatitis2
- No Consequences Or Impact To Patient1
- Perforation1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724597 ↗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 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 ↗MalfunctionMay 9, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINE VIDEOSCOPE HAD WHITE FOREIGN MATERIALS AT AIR-WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133161 ↗MalfunctionMay 6, 2026Device Reprocessing Problem
IT WAS OBSERVED DURING DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS IN AIR/ WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095321 ↗MalfunctionApr 22, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE PRESENTED FOREIGN OBJECTS IN THE AIR WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956632 ↗MalfunctionApr 1, 2026Microbial Contamination of Device
NO ADDITIONAL CUSTOMER REPORTED INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756346 ↗MalfunctionMar 24, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INTESTINAL VIDEOSCOPE EXHIBITED BURNS ON THE DISTAL END C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681424 ↗MalfunctionJan 29, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE AIR WATER CYLINDER AND TUBE HAD FOREIGN OBJECT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208931 ↗MalfunctionDec 20, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858607 ↗MalfunctionDec 18, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843929 ↗MalfunctionSep 9, 2025Overheating of Device; Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER (C-COVER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011931 ↗MalfunctionSep 2, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A STICKY UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937533 ↗MalfunctionAug 18, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826793 ↗MalfunctionAug 14, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE HAD FOREIGN OBJECTS IN THE AIR/WATER (A/W) CYLINDER AND IN THE A/W TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806358 ↗MalfunctionJun 30, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE SUBJECT DEVICE EXHIBITED CLOTTING PROTEIN ON THE A-RUBBER (BENDING SECTION COVER OR DISTAL SHEATH) COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359529 ↗MalfunctionJun 27, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD EXHIBITED LIGHT GUIDE LENS HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345989 ↗MalfunctionMar 10, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS COMING OUT OF THE NOZZLE AND CLOGGING THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21562047 ↗MalfunctionMar 5, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER, TUBE AND THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525912 ↗MalfunctionMay 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19362704 ↗MalfunctionMay 13, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SUBJECT DEVICE TESTED POSITIVE FOR 3 COLONY FORMING UNITS (CFUS) OF ENTEROCOCCUS FAECALIS. 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 19305328 ↗MalfunctionApr 1, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SMALL INTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNKNOWN NUMBER OF COLONY FORMING UNITS (CFUS) OF STENOTROPHOMONAS MALTOPHILIA, AND PSEUDOMONAS SPP. 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 19011912 ↗MalfunctionFeb 26, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, INTESTINAL VIDEOSCOPE EXHIBITED WHITISH FOREIGN MATERIAL WAS FOUND INSIDE THE AIR /WATER TUBE AND THE CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777527 ↗MalfunctionJan 22, 2024Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THE SMALL INTESTINAL VIDEOSCOPE TESTED POSITIVE FOR PERSISTENT COLONIZATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555183 ↗
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- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
- Flexor Parallel G34874Cook Incorporated · endoscopic access overtube, gastroenterology-urology21 reports
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 · each recall links to the FDA recall notice
- 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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