EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180J (UDI 04953170307539)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA II videoscope is an endoscope for looking inside the digestive tract. Many of its 208 reports describe scopes not being cleaned adequately or contamination found on return for service. There is 1 open recall, which began in September 2023 and concerns scopes returned with moisture left in the channel, which could carry contamination. The reports include no deaths or injuries. Reports rose to 47 in the last 12 months, from 29 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
- 202
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 04953170307539), received between Aug 23, 2018 and Sep 28, 2026 — classified as 202 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (92 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately92
- Microbial Contamination of Device46
- Device Reprocessing Problem24
- Poor Quality Image13
- No Display/Image9
- Contamination7
- Contamination /Decontamination Problem4
- Corroded4
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient6
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 202 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the returned device, foreign materials were observed on the air/water tube and air/water cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917632 ↗MalfunctionJun 29, 2026Corroded
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 CORROSION ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651449 ↗MalfunctionJun 2, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE DURING INSPECTION FOR USE. INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364688 ↗MalfunctionJun 1, 2026Corroded
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE LIGHT GUIDE LENS HAD CORROSION. THE ROOT CAUSE OF THE CORROSION COULD NOT BE IDENTIFIED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350322 ↗MalfunctionMay 28, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE THE LIGHT GUIDE LENS, THE AIR/WATER CYLINDER THE AIR/WATER TUBE HAD WHITE FOREIGN MATERIAL. THE ROOT CAUSE OF THE WHITE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319758 ↗MalfunctionMay 22, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLACKOUT IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256655 ↗MalfunctionMay 21, 2026Poor Quality Image
IT WAS REPORTED THAT GASTROINTESTINAL VIDEOSCOPE HAD BLURRY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238986 ↗MalfunctionMay 15, 2026Device Reprocessing Problem; Material Puncture/Hole; Obstruction of Flow; Gas/Air Leak; Material Deformation
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF THERE WAS A HOLE IN THE FRONT OF THE LENS; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THE PROBE COVER AND THE SUCTION TUBE IN UNIVERSAL CORD HAD WHITE FOREIGN MATERIALS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25187048 ↗MalfunctionMay 6, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ADHESIVE OF THE DISTAL SHEATH AND THE ELECTRICAL CONNECTOR OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095571 ↗MalfunctionMay 1, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER CYLINDER AND THE AIR/WATER TUBE OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS AND HAD A NOISY IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058116 ↗MalfunctionApr 29, 2026No Display/Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE'S IMAGE WAS NOT VISIBLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25027977 ↗MalfunctionApr 28, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT GUIDE LENS OF THE GASTROINTESTINAL VIDEOSCOPE HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018227 ↗MalfunctionApr 27, 2026No Display/Image
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25006073 ↗MalfunctionApr 15, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL IN THE AIR WATER CHANNEL ON THE PROBE OF THE DISTAL PROTECTION SLEEVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888651 ↗MalfunctionApr 15, 2026Erratic or Intermittent Display; Poor Quality Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED IMAGE INTERFERENCE AND RED STREAKS ON THE IMAGE. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885754 ↗MalfunctionApr 9, 2026Corroded
IT WAS REPORTED THAT DURING EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CORROSION ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834930 ↗MalfunctionApr 7, 2026No Display/Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799625 ↗MalfunctionMar 30, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED DIRT IN THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719800 ↗MalfunctionMar 16, 2026Poor Quality Image; Microbial Contamination of Device; Failure to Clean Adequately
IT WAS REPORTED THAT, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 23 COLONY FORMING UNITS (CFUS) OF 200 MICROLITRES BACTERIA OR FUNGI, 11 CFU OF 200 MICROLITRES STENOTROPHOMONAS MALTOPHILIA, AND 12 CFU OF 200 MICROLITRES OCHROBACTRUM INTERMEDIUM. 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 24604676 ↗MalfunctionMar 10, 2026Device Reprocessing Problem; No Display/Image; Flare or Flash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND AIR/WATER CHANNEL. IN ADDITION, THE DISTAL END COVER HAD A BURN AND THERE WAS NO IMAGE ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24556661 ↗MalfunctionMar 5, 2026Device Reprocessing Problem
DURING THE DEVICE INSPECTION OF THE GASTROINTESTINAL VIDEOSCOPE, FOREIGN MATERIAL WAS OBSERVED ON THE LIGHT GUIDE ROD LENS AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524811 ↗MalfunctionMar 5, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED NO ELECTRICAL CONTINUITY DUE TO CORROSION ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523676 ↗MalfunctionFeb 20, 2026No Display/Image
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED NO IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401325 ↗MalfunctionFeb 19, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BURNT C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394429 ↗MalfunctionFeb 17, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE AIR WATER CYLINDER AND AIR WATER TUBE HAD FOREIGN OBJECTS (WHITE FOREIGN MATERIAL). THE C-COVER ALSO HAD FOREIGN OBJECTS AND ADHESIVE ON THE BENDING SECTION COVER CONTAINED FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369384 ↗
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
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- 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 · each recall links to the FDA recall notice
- 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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