EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 (UDI 04953170202247)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 EVIS EXERA II videoscope is a flexible camera used to examine the digestive tract. Many of its 288 reports describe cleaning or reprocessing problems, microbial contamination and poor or blurry images, and some describe the screen going blank. The reports include 6 injuries and no deaths. 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
- 286
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 04953170202247), received between May 11, 2018 and Sep 30, 2026 — classified as 6 injuries, 280 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (93 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 Adequately93
- Microbial Contamination of Device53
- Poor Quality Image50
- Device Reprocessing Problem39
- No Display/Image17
- Overheating of Device6
- Thermal Decomposition of Device6
- Contamination5
Patient problems
- No Clinical Signs, Symptoms or Conditions238
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient7
- Bacteremia3
- Chills3
- Fever3
- Hemorrhage/Blood Loss/Bleeding3
- Malaise3
Recent adverse event reports
The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954041 ↗MalfunctionSep 30, 2026Mechanical Jam
The customer reported that the angulation knob was stuck and would not move during an unspecified procedure involving an Olympus Gastrointestinal Videoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951217 ↗MalfunctionSep 22, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860452 ↗MalfunctionAug 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376895 ↗MalfunctionAug 14, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262071 ↗MalfunctionAug 10, 2026Thermal Decomposition of Device
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates that the C-cover has a burn. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195170 ↗MalfunctionJun 26, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE REPAIR TECHNICIAN INDICATES THAT AIR/WATER CYLINDER AND TUBE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636814 ↗MalfunctionJun 9, 2026Erratic or Intermittent Display
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 A GRAINY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447793 ↗MalfunctionJun 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE EVALUATION, A FOREIGN BODY IN THE WATER/AIR CHANNEL WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438467 ↗MalfunctionJun 5, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE EVALUATION, THE AIR/WATER VALVE SOCKET WITH A FOREIGN OBJECT WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414371 ↗MalfunctionJun 1, 2026Erratic or Intermittent Display; No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A DISTORTED IMAGE AND THEN A COMPLETE LOSS OF IMAGE. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350420 ↗MalfunctionMay 26, 2026Device Reprocessing Problem
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SEALING CAP NO LONGER HOLDS. THIS DOES NOT CONSTITUTE AN MDR-REPORTABLE EVENT. HOWEVER, AN MDR-REPORTABLE FAILURE WAS IDENTIFIED DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE FOREIGN OBJECTS WERE OBSERVED IN THE AIR/WATER CYLINDER AND THE AIR /WATER TUBE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279330 ↗MalfunctionMay 26, 2026Corroded; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND CORROSION IN THE SUCTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279300 ↗MalfunctionMay 20, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237451 ↗MalfunctionMay 18, 2026Device Reprocessing Problem; Corroded
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A DIRTY CHARGED COUPLED DEVICE-FLEXIBLE PRINTED CIRCUIT BOARD AND A CORRODED LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200672 ↗MalfunctionMay 13, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A STICKY GRIP SURFACE ON THE CONTROL BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164549 ↗MalfunctionMay 13, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS FROM THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162232 ↗MalfunctionApr 27, 2026Erratic or Intermittent Display
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE IMAGE OF THE GASTROINTESTINAL VIDEOSCOPE WAS NOISY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009594 ↗MalfunctionApr 27, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL ON THE BENDING SECTION COVER AND CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000676 ↗MalfunctionApr 22, 2026No Display/Image; Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD NOISE IMAGE, NO IMAGE, AND THE CHARGED COUPLED DEVICE FLEXIBLE PRINTED CIRCUIT WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957758 ↗MalfunctionApr 21, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945615 ↗MalfunctionApr 21, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943411 ↗MalfunctionApr 17, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FLICKERING IMAGE. THE ISSUE HAD OCCURRED DURING INSPECTION FOR USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911678 ↗MalfunctionApr 14, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A NOISY IMAGE. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873960 ↗MalfunctionApr 11, 2026Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24848599 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page