EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N (UDI 04953170275425)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus GIF XP180N gastrointestinal video scope is a flexible endoscope used to look inside the stomach and intestines. The 36 reports mostly describe cleaning and reprocessing problems, plus poor image quality and bits of foreign material or corrosion found inside the scope during service. All36 reports are malfunctions with no deaths and no injuries, and no recalls name this device.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04953170275425), received between Sep 14, 2018 and Jun 11, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (14 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 Adequately14
- Device Reprocessing Problem9
- Poor Quality Image6
- Contamination2
- Material Deformation2
- Contamination /Decontamination Problem1
- Corroded1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR TECHNICIAN INDICATES THAT FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476965 ↗MalfunctionApr 27, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL ON THE ADHESIVE AROUND THE OBJECTIVE LENS AND ON THE DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24998803 ↗MalfunctionApr 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECT IN THE AIR/WATER CYLINDER AND TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816241 ↗MalfunctionApr 6, 2026Material Deformation
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE INSTRUMENT CHANNEL OF THE GASTROINTESTINAL VIDEOSCOPE WAS DAMAGED AND A FORCEPS COULD NOT BE INSERTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792916 ↗MalfunctionMar 18, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD FOREIGN OBJECTS INSIDE THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630100 ↗MalfunctionFeb 4, 2026Corroded; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A LIGHT GUIDE-COVER GLASS HAS CORROSION AND DENT ON CHANNEL-TUBE, FORCEPS CANNOT BE INSERTED SMOOTHLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256579 ↗MalfunctionJan 27, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CYLINDER, AIR/WATER TUBE, NOZZLE, OBJECTIVE LENS AND PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193190 ↗MalfunctionJan 20, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL FROM THE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121029 ↗MalfunctionNov 10, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE PLASTIC DISTAL END COVER (C-COVER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509136 ↗MalfunctionSep 19, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE AIR/WATER CYLINDER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095978 ↗MalfunctionJul 30, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL FOUND INSIDE THE AIR/WATER TUBE (A/W-TUBE) AND THE AIR/WATER CYLINDER (A/W-CYLINDER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 22662766 ↗MalfunctionJul 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE CONNECTING TUBE ON THE GASTROINTESTINAL VIDEOSCOPE IS PROTRUDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587802 ↗MalfunctionJun 25, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER TUBE, AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327851 ↗MalfunctionJun 19, 2025Device Reprocessing Problem; Device Reprocessing Problem
DURING DEVICE EVALUATION, THE AIR/WATER CYLINDER AND TUBE OF THE SUBJECT DEVICE WAS CLOGGED WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292279 ↗MalfunctionMar 17, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21622581 ↗MalfunctionMar 7, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551707 ↗MalfunctionJan 30, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE PLASTIC DISTAL END COVER (C-COVER). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21279990 ↗MalfunctionSep 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN OBJECTS IN AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278443 ↗MalfunctionSep 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE EXHIBITED AIR/WATER (INSUFFLATION) CHANNEL CLOGGED WITH FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20229594 ↗MalfunctionAug 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL INSIDE OF THE AIR/WATER CYLINDER AND TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19907773 ↗MalfunctionMay 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19384571 ↗MalfunctionDec 15, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED IMAGE ISSUES ¿ THE IMAGE COULD NOT BE SEEN PROPERLY. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE REVEALED THAT FOREIGN MATERIAL WAS PRESENT IN THE NOZZLE. ADDITIONALLY, THE ADHESIVE AROUND THE LIGHT GUIDE LENS AND CHARGED COUPLED DEVICE LENS HAD FOREIGN MATERIAL. THIS WAS ATTRIBUTED TO INADEQUATE CLEANING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334222 ↗MalfunctionDec 1, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED THE INSERTION TUBE OF THE GASTROINTESTINAL VIDEOSCOPE NEEDED TO BE REPAIRED. THERE WAS NO REPORT OF PATIENT HARM, INJURY, OR PROCEDURAL DELAY. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THERE WAS FOREIGN MATERIAL IN THE AIR/WATER TUBE AND CYLINDER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18247351 ↗MalfunctionSep 6, 2023Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A DAMAGED DISTAL SHEATH. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND THERE WAS FOREIGN MATERIAL FOUND ON THE PLASTIC DISTAL END COVER AND ON THE LIGHT GUIDE LENS ADHESIVE. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695594 ↗MalfunctionFeb 10, 2023Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD A BLURRY IMAGE. THE SUBJECT WAS UNABLE TO BE RECOGNIZED AND THE IMAGE DID NOT RETURN. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16357308 ↗
Other Endoscope, accessories, narrow band spectrum devices
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- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
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- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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
- 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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