EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180 (UDI 04953170339745)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 GIF-H180 gastrointestinal video scope is a flexible gastroscope used for endoscopy. Most of the 76 reports describe cleaning and reprocessing problems — residue left in the channel after cleaning, corrosion, and debris or water found inside the scope, along with a few image quality complaints. Reports mention 6 injuries and no deaths. One open recall, started in September 2023, concerns scopes returned after repair having a wet channel because the air-drying process was not validated, which can allow contamination and infection risk.
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
- 76
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 04953170339745), received between Aug 2, 2020 and Sep 23, 2026 — classified as 6 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (28 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 Adequately28
- Device Reprocessing Problem17
- Poor Quality Image7
- Adverse Event Without Identified Device or Use Problem4
- Microbial Contamination of Device4
- Corroded3
- Connection Problem2
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Hemorrhage/Blood Loss/Bleeding2
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Unspecified Gastrointestinal Problem1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Melted
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865920 ↗MalfunctionJun 11, 2026Corroded
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A LEAKING BUTTON. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING ONSITE INSPECTION OF THE DEVICE, CORROSION ON THE AIR/WATER CYLINDER NUT WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480631 ↗MalfunctionMay 20, 2026Corroded
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF SCOPE LEAK AND ANGULATION ISSUE DURING REPROCESSING; THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THERE WAS CORROSION IN THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25228445 ↗MalfunctionMay 13, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162750 ↗MalfunctionMay 11, 2026Residue After Decontamination
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138814 ↗MalfunctionApr 28, 2026Corroded; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED NOISE IN THE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019289 ↗MalfunctionApr 27, 2026Failure to Clean Adequately
NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24998364 ↗MalfunctionMar 30, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE AIR WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729236 ↗MalfunctionMar 25, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688045 ↗MalfunctionMar 16, 2026Break; Device Reprocessing Problem; Crack; Electrical /Electronic Property Problem; Material Separation; Gas/Air Leak; Material Deformation; Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE AIR AND WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 24606762 ↗MalfunctionMar 9, 2026No Display/Image; Image Display Error/Artifact
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A NOISY IMAGE AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550180 ↗MalfunctionFeb 17, 2026Output Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A LACK OF LIGHT OR DEPTH TO THE IMAGE, OR NO LIGHT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370534 ↗MalfunctionFeb 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS (WHITE FOREIGN MATERIAL) IN THE AIR-WATER (AW) CYLINDER AND IN THE AIR-WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334378 ↗MalfunctionDec 23, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879284 ↗MalfunctionNov 27, 2025No Device Output; No Device Output
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE'S LIGHT FUNCTION WAS NOT WORKING. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665541 ↗MalfunctionNov 20, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610478 ↗MalfunctionNov 10, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509381 ↗MalfunctionOct 23, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THE ISSUE WAS FOUND DURING SERVICE/MAINTENANCE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367169 ↗MalfunctionAug 26, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DIRT ON ANGLE KNOB O-RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898896 ↗MalfunctionAug 25, 2025Failure to Clean Adequately; Failure to Clean Adequately
THE DEVICE EVALUATION FOUND THE LIGHT GUIDE LENS OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WAS NO REPORT ON THE SUBJECT DEVICE BEING USED IN PROCEDURE AFTER THE SUGGESTED EVENT WAS REVIEWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22889941 ↗MalfunctionJul 15, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT EVALUATION EXHIBITED FOREIGN MATERIAL IN THE AIR WATER TUBE AND IN THE AIR WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22511954 ↗MalfunctionJun 16, 2025Overheating of Device; Overheating of Device
DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN AT THE DISTAL END OF THE DEVICE ON THE CAMERA COVER. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213208 ↗MalfunctionMar 5, 2025Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNSPECIFIED NUMBER OF COLONY FORMING UNITS (CFUS) OF TWO VARIETIES OF KLEBSIELLA. IT WAS NOT SPECIFIED WHICH CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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 21526230 ↗InjuryNov 21, 2024Connection Problem; Connection Problem
IT WAS REPORTED DURING A FINE NEEDLE BIOPSY PROCEDURE SET UP FOR A SUSPECTED PANCREATIC MASS, THE SUTURING SYSTEM (NON-OLYMPUS) WAS PLACED IN AN OLYMPUS DOUBLE CHANNEL SCOPE, AND IT WAS DISCOVERED THAT THE DOUBLE CHANNEL SCOPE HAD CONNECTIVITY ISSUES CAUSING NO IMAGE. THE PATIENT WAS ALREADY SEDATED AND INTUBATED AT THE TIME OF MALFUNCTION. DUE TO NO IMAGE ISSUE THE PROCEDURE WAS CANCELLED AND RESCHEDULED THE NEXT DAY AND COMPLETED SUCCESSFULLY WITH ANOTHER SCOPE AND ANOTHER SUTURING SYSTEM. NO FURTHER INFORMATION IS AVALIABLE AT THE TIME OF THE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747007 ↗InjuryNov 21, 2024Connection Problem; Connection Problem
IT WAS REPORTED DURING A FINE NEEDLE BIOPSY PROCEDURE SET UP FOR A SUSPECTED PANCREATIC MASS, THE SUTURING SYSTEM (NON-OLYMPUS) WAS PLACED IN AN OLYMPUS DOUBLE CHANNEL SCOPE, AND IT WAS DISCOVERED THAT THE DOUBLE CHANNEL SCOPE HAD CONNECTIVITY ISSUES CAUSING NO IMAGE. THE PATIENT WAS ALREADY SEDATED AND INTUBATED AT THE TIME OF MALFUNCTION. DUE TO NO IMAGE ISSUE THE PROCEDURE WAS CANCELLED AND RESCHEDULED THE NEXT DAY AND COMPLETED SUCCESSFULLY WITH ANOTHER SCOPE AND ANOTHER SUTURING SYSTEM. NO FURTHER INFORMATION IS AVALIABLE AT THE TIME OF THE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20746965 ↗
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
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 death302 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page