EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180 (UDI 04953170339752)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-2TH180 THERAPEUTIC 2-CHANNEL HDTV GA · 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 scope used to look inside the stomach and upper digestive tract. Its 149 reports describe the scope not being cleaned adequately, a blank or poor image, and contamination inside the device. The reports include 3 injuries and no deaths. Reports rose to 96 in the last 12 months from 20 in the 12 months before. 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
- 137
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 04953170339752), received between Jun 5, 2020 and Sep 28, 2026 — classified as 3 injuries, 134 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (45 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 Adequately45
- No Display/Image25
- Device Reprocessing Problem16
- Contamination9
- Microbial Contamination of Device7
- Poor Quality Image7
- Erratic or Intermittent Display4
- Dent in Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions130
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Abscess1
- Cellulitis1
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
- Pancreatitis1
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026No Display/Image; Poor Quality Image
It was reported that the Gastrointestinal Videoscope had a fuzzy image. Changing the cable did not resolve the issue. The image eventually disappeared and did not return. The issue occurred during device setup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913628 ↗MalfunctionSep 25, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal videoscope to the service center for evaluation related to a separate issue. During the initial device analysis, unknown foreign material was observed within the nozzle. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898450 ↗MalfunctionJun 29, 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 BLACK FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653354 ↗MalfunctionJun 25, 2026Thermal Decomposition of Device
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 BURNED BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629900 ↗MalfunctionJun 11, 2026Complete Blockage
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470873 ↗MalfunctionMay 27, 2026Failure to Clean Adequately
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FIBERS IN THE CHANNEL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302096 ↗MalfunctionMay 27, 2026Material Deformation
THE INITIAL CUSTOMER ALLEGATION OF DISTAL END OF 3.7 BIOPSY CHANNEL IS BLOCKED WAS FOUND TO BE NOT REPORTABLE. HOWEVER, IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED SCRAPE MARKS IN THE INSTRUMENT CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301397 ↗MalfunctionMay 26, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF SOMETHING IS STUCK IN IT; THEY USED A CAMERA TO CHECK, AND SOMETHING IS STUCK; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE INSERTION TUBE HAD STICKY RESIDUE. THE PROBABLE ROOT CAUSE WAS COMPONENT FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280335 ↗MalfunctionMay 22, 2026Erratic or Intermittent Display; No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A STATIC IMAGE ON ONE VIDEO PROCESSOR AND NO IMAGE ON ANOTHER VIDEO PROCESSOR. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256244 ↗MalfunctionMay 18, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WAS NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25204155 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF CLOGGED SUCTION AND BUTTON BROKEN, THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL STUCK INSIDE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148079 ↗MalfunctionMay 8, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125582 ↗MalfunctionApr 28, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL CLOGGING THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016080 ↗MalfunctionApr 27, 2026No Display/Image; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A B30 SCOPE COMMUNICATION ERROR AND A NO IMAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25006450 ↗MalfunctionApr 15, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED RESIDUE IN THE NOZZLE THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24890676 ↗MalfunctionApr 15, 2026Difficult to Insert
IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE UNDER SEDATION, THE GASTROINTESTINAL VIDEOSCOPE HAD DIFFICULTY PASSING THE EQUIPMENT THROUGH THE CHANNEL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885486 ↗MalfunctionApr 11, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845870 ↗MalfunctionApr 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BLACK FOREIGN OBJECT STUCK ON THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815798 ↗MalfunctionApr 7, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED SCATTERED DEBRIS, TEAR MARKS, AND METAL FOREIGN MATERIAL IN THE FORCEPS PASSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802450 ↗MalfunctionApr 6, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE AND THE IMAGE WAS COMPLETELY BLACK. THE ISSUE WAS FOUND BEFORE SEDATION OF AN UNKNOWN PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791630 ↗MalfunctionApr 6, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD BLACK FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790604 ↗MalfunctionApr 2, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE¿S FORCEPS PASSAGE SCATTERED BLACK DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765259 ↗MalfunctionApr 1, 2026Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS) OF E COLI. THE DEVICE WAS RETESTED AND IT TESTED POSITIVE FOR 4 CFUS OF E. 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 24753214 ↗MalfunctionMar 30, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730212 ↗MalfunctionMar 30, 2026Erratic or Intermittent Display; No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE AND ONLY STATIC WAS DISPLAYED. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729680 ↗
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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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