EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180 (UDI 04953170339943)Recalls & reported problems
Olympus Medical Systems Corp. · "SIF-Q180 SMALL INTESTINAL VIDEOSCOPE WIT" · 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 EVIS EXERA II small intestinal videoscope is a flexible scope used to view the small intestine. Its 92 reports, with 33 injuries and 1 death, describe cleaning problems, missing images, and burn or melt marks on parts. Some reports mention bleeding, perforation, or esophageal tears. No recalls name this device. Reports for the last 12 months (35) are far more than in the previous 12 months (6).
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
- 96
- Deaths reported
- 1
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 04953170339943), received between Aug 26, 2021 and Sep 28, 2026 — classified as 1 death, 33 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (24 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
- Adverse Event Without Identified Device or Use Problem33
- Failure to Clean Adequately24
- No Display/Image11
- Melted4
- Microbial Contamination of Device4
- Device Reprocessing Problem3
- Residue After Decontamination3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- Hemorrhage/Blood Loss/Bleeding11
- Perforation7
- Hypoxia6
- Laceration(s) of Esophagus6
- Bradycardia5
- Pancreatitis5
- Abdominal Pain4
Recent adverse event reports
The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Erratic or Intermittent Display; No Display/Image
The customer reported the small intestinal videoscope had no image during reprocessing. During the initial evaluation of the device it was observed, intermit/flicker Image. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922029 ↗MalfunctionSep 22, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862918 ↗MalfunctionSep 21, 2026No Display/Image
The customer reported no image during Maintenance involving an Olympus small intestinal videoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846189 ↗MalfunctionSep 8, 2026Failure to Clean Adequately
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, a foreign material was found in the nozzle. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671892 ↗MalfunctionAug 31, 2026Contamination
The customer reported that the small intestinal videoscope had a biodurden stuck inside the unit. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50526205 ↗MalfunctionAug 25, 2026Thermal Decomposition of Device
The customer reported that the Small Intestinal Videoscope had a separate issue. During the initial evaluation, burn marks were observed on the distal-end plastic. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430336 ↗MalfunctionJul 27, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005960 ↗MalfunctionJul 21, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR CENTER IDENTIFIED WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25895029 ↗MalfunctionJun 5, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE EVALUATION, DARK RESIDUE IN THE LENSES WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416328 ↗MalfunctionJun 3, 2026Partial Blockage
THE CUSTOMER REPORTED STENT STUCK IN SCOPE DURING REPROCESSING INVOLVING AN OLYMPUS SMALL INTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382606 ↗MalfunctionMay 28, 2026Melted; Failure to Clean Adequately
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT MELTED C-COVER, WHITE RESIDUE IN SUCTION AND AIR WATER CHANNELS WAS FOUND. IT WAS DETERMINED THAT THE C-COVER, SUCTION AND AIR WATER CHANNELS NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325419 ↗MalfunctionMay 28, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE SMALL INTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED WHITE RESIDUE INSIDE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317320 ↗MalfunctionMay 14, 2026No Display/Image
IT WAS REPORTED THAT THE SMALL INTESTINAL VIDEOSCOPE HAD A BLACKOUT. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168085 ↗MalfunctionApr 13, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE DISTAL END PLASTIC COVER AND DISTAL END INSULATION OF THE SMALL INTESTINAL VIDEOSCOPE WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861456 ↗MalfunctionApr 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED WHITE RESIDUE IN AIR WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821933 ↗MalfunctionApr 6, 2026Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE'S DISTAL END PLASTIC COVER HAD BURNT MARK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792815 ↗MalfunctionApr 3, 2026No Display/Image
IT WAS REPORTED THAT THE FROM THE SMALL INTESTINAL VIDEOSCOPE HAD A BLACK IMAGE WITH A SMALL COLORED AREA AND NO OVERALL PICTURE. THE ISSUE OCCURRED DURING INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781226 ↗MalfunctionMar 24, 2026Melted
LIGHT GUIDE LENS IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682361 ↗MalfunctionMar 20, 2026No Display/Image
IT WAS REPORTED THAT THE SMALL INTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651246 ↗MalfunctionMar 18, 2026Failure to Clean Adequately
IT WAS REPORTED THE SMALL INTESTINAL VIDEOSCOPE SCOPE HAD BLACK RESIDUE/DEBRIS FROM INNER PART OF SCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628138 ↗MalfunctionFeb 18, 2026Mechanical Jam
IT WAS REPORTED THAT THE SMALL INTESTINAL VIDEOSCOPE HAD A STENT STUCK IN THE BIOPSY PORT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380525 ↗MalfunctionFeb 18, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD DEBRIS INSIDE THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374280 ↗MalfunctionFeb 16, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE EXHIBITED DEBRIS INSIDE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24348326 ↗MalfunctionFeb 2, 2026No Display/Image
IT WAS REPORTED THAT THE SMALL INTESTINAL VIDEOSCOPE DISPLAYED NO IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231121 ↗MalfunctionJan 28, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SMALL INTESTINAL VIDEOSCOPE HAD FLUORINE COMPOUNDS IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202014 ↗
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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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