EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 (UDI 04953170339776)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-H180 HDTV NBI GASTROVIDEOSCOPE · 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 EVIS EXERA II gastroscope is a flexible camera used to look inside the upper digestive tract. Many of the 314 reports describe a blank or poor screen image, and others describe incomplete cleaning. There was 1 death and 8 injuries reported, and no recalls name this device. Reports rose sharply to 164 in the latest 12 months from 16 in the 12 months before.
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
- 302
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 302 adverse event reports that list this exact device (DI 04953170339776), received between Apr 24, 2019 and Jul 9, 2026 — classified as 1 death, 8 injuries, 293 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (89 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 Adequately89
- Poor Quality Image67
- No Display/Image46
- Device Reprocessing Problem28
- Erratic or Intermittent Display25
- Microbial Contamination of Device8
- Adverse Event Without Identified Device or Use Problem7
- Contamination7
Patient problems
- No Clinical Signs, Symptoms or Conditions288
- Perforation3
- Unspecified Gastrointestinal Problem3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- No Patient Involvement2
- Pneumothorax2
- Dysphagia/ Odynophagia1
Recent adverse event reports
The 25 most recent of 302 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026No Display/Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TECHNICAL ASSISTANCE INDICATES THAT THERE WAS NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765081 ↗MalfunctionJul 6, 2026Microbial Contamination of Device
THE CUSTOMER REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED AN UNEXPECTED CONTAMINATION. DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BALLOON DILATION AND BIOPSY, IT WAS DISCOVERED THAT THE SCOPE HAD BEEN USED ON A PATIENT DIAGNOSED WITH CREUTZFELDT-JAKOB DISEASE (CJD), RESULTING IN POTENTIAL CONTAMINATION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 25721437 ↗MalfunctionJul 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678884 ↗MalfunctionJul 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION FOR A SEPARATE ISSUE. DURING TESTING, DEBRIS IN THE LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25677319 ↗MalfunctionJun 29, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER WITH NO REPORTED COMPLAINT. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652940 ↗MalfunctionJun 26, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE DEVICE EXHIBITED A FUZZY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25639386 ↗MalfunctionJun 23, 2026Thermal Decomposition of Device; Corroded; Degraded; Peeled/Delaminated; Gas/Air Leak; Material Deformation; Moisture or Humidity Problem; Material Split, Cut or Torn; Key or Button Unresponsive/not Working
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN MARK ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25597457 ↗MalfunctionJun 15, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED WHITE RESIDUE IN AIR/WATER CHANNEL AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504380 ↗MalfunctionJun 10, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN MATERIAL ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459742 ↗MalfunctionJun 10, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE PRODUCED AN INTERMITTENT IMAGE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459715 ↗MalfunctionJun 9, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN MATERIAL IN THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443774 ↗MalfunctionJun 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE OBJECTIVE LENS WAS DIRTY. THE ROOT CAUSE OF THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355223 ↗MalfunctionMay 29, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE IMAGE WAS FLICKERING. THE ROOT CAUSE WAS COMPONENT FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334177 ↗MalfunctionMay 27, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, THE TECHNICAL ASSISTANCE CENTER (TAC) REPRESENTATIVE INDICATED THAT THE AIR/WATER CHANNEL AND THE AIR/WATER CYLINDER HAD WHITE FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301679 ↗MalfunctionMay 27, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF WHEN REPROCESSING, BLOCKED CHANNEL ERROR OCCURRED; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE NOZZLE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298337 ↗MalfunctionMay 20, 2026Poor Quality Image
IT WAS REPORTED THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS NOT CLEAR. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231948 ↗MalfunctionMay 19, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222867 ↗MalfunctionMay 19, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF FOGGY LIGHT GUIDE LENS; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THERE WAS RESIDUE ON THE OBJECTIVE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217613 ↗MalfunctionMay 19, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215740 ↗MalfunctionMay 14, 2026Poor Quality Image
IT WAS REPORTED THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS BLURRY. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176787 ↗MalfunctionMay 8, 2026No Display/Image
IT WAS REPORTED THAT DURING INSPECTION FOR USE, THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127179 ↗MalfunctionApr 28, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD BLACK DISPLAY. THE EVENT HAD OCCURRED DURING PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019334 ↗MalfunctionApr 24, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO PICTURE AND BLACK SCREEN. THE ISSUE OCCURRED DURING UPPER ENDOSCOPY DIAGNOSTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THE INTENDED PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984376 ↗MalfunctionApr 23, 2026Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968845 ↗MalfunctionApr 23, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL STUCK ON THE SUCTION CYLINDER PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965357 ↗
Other Gastroscope and accessories, flexible/rigid devices
- PENTAX Medical EG29-i10cHoya Corporation · Gastroscope And Accessories, Flexible/Rigid1,623 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid349 reports
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 recalls72 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.
How reports and recalls are matched · Editorial policy · Report an error on this page