EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2TH180 (UDI 04953170275463)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170275463), received between Jun 6, 2018 and Jan 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209719 ↗
• MalfunctionJan 19, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED DIRT ON THE LIGHT GUIDE (LG) LENS, WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER (A/W) CYLINDER, AND WHITE FOREIGN MATERIAL INSIDE THE AIR/WATER (A/W) CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108459 ↗
• MalfunctionJul 31, 2025Melted; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURNED PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22683212 ↗
• MalfunctionSep 20, 2024Thermal Decomposition of Device; Failure to Clean Adequately; Thermal Decomposition of Device; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN ON THE PLASTIC DISTAL END COVER AND WHITE FOREIGN OBJECTS ON THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268045 ↗
• MalfunctionDec 22, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE THREADED CONNECTION OF THE FLUSHING CHANNEL ON THE GASTROINTESTINAL VIDEOSCOPE HAS BROKEN OFF. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE JET TUBE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388084 ↗
• MalfunctionAug 24, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE SCOPE WAS SAMPLED ONCE. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS HOMINIS AND 1 CFUS OF CARYNEBACTERIUM MUCIFACIENS. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17616534 ↗
• MalfunctionApr 6, 2022Microbial Contamination of Device; Microbial Contamination of Device

  AS REPORTED, THE ENDOSCOPE FAILED THE HYGIENE TEST DESPITE MULTIPLE CLEANINGS (MANUAL AND MECHANICAL). THE CUSTOMER THEN SENT THE DEVICE TO RRC (REGIONAL REPAIR CENTER) OLYMPUS HAMBURG FOR FURTHER INVESTIGATION. THE CUSTOMER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14032022 ↗
• MalfunctionJun 4, 2020Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED TO OLYMPUS THAT THERE WAS A SERVICE PORTAL CHANNEL MALFUNCTION AND THERE WAS A BIOPSY VALVE NEEDLE STUCK IN RED CHANNEL BIOPSY. IT WAS REPORTED THAT THE REPORTED EVENT OCCURRED DURING REPROCESSING AND NOT DURING A PROCEDURE IMMEDIATELY PRIOR TO REPROCESSING.

  Patient problems: No Patient Involvement

  MAUDE report 10121747 ↗
• MalfunctionJul 25, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR THE FOLLOWING BACTERIA. THE INSTRUMENT CHANNEL A: MICROCOCCUS SP. (2CFU/20ML). THE AUXILIARY WATER CHANNEL: PSEUDOMONAS SP. (5CFU/20ML). THE INSTRUMENT CHANNEL B: NO MICROBIAL GROWTH. THE DISTAL END: NO MICROBIAL GROWTH. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (BELIMED). THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8825483 ↗
• MalfunctionJun 6, 2018Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR FOLLOWING BACTERIA DURING A SURVEILLANCE CULTURING TEST AT THE FACILITY ON (B)(6) 2018. BIOPSY CHANNEL 1: STAPHYLOCOCCUS AUREUS (990CFU/ML), BIOPSY CHANNEL 2: STAPHYLOCOCCUS AUREUS (1CFU/ML), AUXILIARY CHANNEL: STAPHYLOCOCCUS AUREUS (990CFU/ML). IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR FOLLOWING BACTERIA (18CFU/ENDOSCOPE) DURING ADDITIONAL MICROBIOLOGICAL CULTURING TEST AT THE FACILITY ON (B)(6) 2018. BIOPSY CHANNEL 1 :COAGULASE NEGATIVE STAPHYLOCOCCUS AUREUS (1CFU/ML), AIR/WATER CHANNEL: STAPHYLOCOCCUS AUREUS (990CFU/ML), AUXILIARY CHANNEL: MICROCOCCUS (1CFU/ML). OTHER DETAILED INFORMATION SUCH AS REPROCESSING METHOD WAS NOT PROVIDED FROM THE FACILITY BUT THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7576653 ↗