EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180 (UDI 04953170339080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04953170339080), received between Jan 27, 2022 and Jun 24, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Poor Quality Image

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR TECHNICIAN INDICATES THAT A BLURRY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612797 ↗
• MalfunctionMay 8, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD UNKNOWN FOREIGN OBJECT IN NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128468 ↗
• MalfunctionApr 15, 2026Connection Problem

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE WAS NOT ABLE TO CONNECT TO THE TOWER. THE ISSUE WAS FOUND DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884931 ↗
• MalfunctionApr 7, 2026Contamination

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800476 ↗
• MalfunctionMar 17, 2026Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLURRED IMAGE . THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618951 ↗
• MalfunctionJan 27, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, WHITE RESIDUE WAS PRESENT IN THE AIR/WATER CHANNEL AND THE AIR/WATER CYLINDER OF THE GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189994 ↗
• MalfunctionJan 21, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE RESIDUE IN AIR/WATER CHANNEL AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136423 ↗
• MalfunctionDec 30, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE RESIDUE IN THE AIR WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923360 ↗
• MalfunctionDec 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED RUBBER TYPE FOREIGN MATERIAL IN NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881417 ↗
• MalfunctionDec 3, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705796 ↗
• MalfunctionJun 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE WAS CLOGGED WITH BLACK DEBRIS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609261 ↗
• MalfunctionApr 24, 2024Microbial Contamination of Device; Microbial Contamination of Device

  THE USER PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS. THIRD SAMPLING. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: ALL CHANNELS. CFU: <1CFU/100ML. BACTERIAL IDENTIFICATION: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176708 ↗
• MalfunctionApr 19, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE PROBE COVER, OBJECTIVE AND LIGHT GUIDE LENS HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148965 ↗
• MalfunctionFeb 21, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE GASTROINTESTINAL VIDEOSCOPE WAS REPROCESSED WITHOUT AN AUXILIARY WATER CHANNEL CONNECTOR, DID NOT DISINFECT THE LINES, AND DID NOT KNOW HOW TO MICROTEST THE REPROCESSOR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754069 ↗
• MalfunctionFeb 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A CLOGGED NOZZLE WITH BLACK DEBRIS IN IT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723166 ↗
• MalfunctionDec 13, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOSCOPE REQUIRES TESTING FOR BLOCKAGES. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE NOZZLE WAS CLOGGED WITH BLACK DEBRIS. 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 18323581 ↗
• MalfunctionOct 17, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD AN INSUFFLATION PROBLEM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE NOZZLE WAS CLOGGED BY AN AMALGAM OF FIBROUS MATERIAL. 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 17949950 ↗
• MalfunctionOct 9, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD NO FLOW FROM THE MAIN AIR/WATER SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING REPROCESSING 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 17902180 ↗
• MalfunctionOct 2, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE SUCTION AND INSUFFLATION CHANNELS DID NOT WORK. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT PLASTIC DISTAL END COVER HAD FOREIGN MATERIAL. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852159 ↗
• MalfunctionJun 14, 2023Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately

  A USER FACILITY REPORTED TO OLYMPUS THAT THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD NO INSUFFLATION DESPITE CHANGE OF PLUG. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIAL WAS FOUND CLOGGED IN THE SCOPE CHANNEL DUE TO INSUFFICIENT CLEANING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130909 ↗
• MalfunctionJan 4, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD LEAKAGE FROM THE DISTAL END. THE ISSUE WAS FOUND DURING REPROCESSING. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE CHANNEL TUBE WAS CLOGGED WITH FOREIGN MATERIAL. 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 16096220 ↗
• MalfunctionDec 9, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT WHILE PERFORMING REPROCESSING TRAINING ON THE TJF-Q190V SCOPE, THE ESS OBSERVED THAT THE CUSTOMER SITE WAS WASHING THREE (3) SCOPES (ENF-VH, ENF-V3 AND GIF-N180) IN THE OER-ELITE INSTEAD OF THE RECOMMENDED TWO (2). THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955274 ↗
• MalfunctionNov 13, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THERE WERE AIR/WATER FLOW ISSUES FROM THE AIR/WATER FLOW SYSTEM OF THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO REPORT OF PATIENT HARM OR IMPACT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, THE AIR/WATER NOZZLE WAS FOUND TO BE CLOGGED WITH FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE FOREIGN MATERIAL FOUND DURING EVALUATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786255 ↗
• MalfunctionJan 27, 2022Device Reprocessing Problem; Material Deformation; Device Reprocessing Problem; Material Deformation

  IT WAS REPORTED TO OLYMPUS THAT EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAS A LEAK. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE REPAIR CENTER FOUND FOREIGN MATERIAL CANNOT BE REMOVED EVEN IF THE CORRECT REPROCESS IS PERFORMED DUE TO THE BUCKLING OF THE CHANNEL. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND AT ESTIMATION. THERE WAS NO REPORT OF DEATH, HARM OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13372676 ↗