EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N (UDI 04953170339097)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170339097), received between Jan 25, 2022 and Jun 17, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR TECHNICIAN INDICATES THAT FOREIGN MATERIAL CLOGGED IN THE NOZZLE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541558 ↗
• MalfunctionMar 30, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731627 ↗
• MalfunctionFeb 10, 2026Failure to Clean Adequately

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A DISPOSABLE BUTTON STUCK IN THE CHANNEL. THE EVENT OCCURRED AT INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305806 ↗
• MalfunctionFeb 9, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CLOGGED NOZZLE WITH BLACK MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293094 ↗
• MalfunctionFeb 6, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD WHITE RESIDUE INSIDE THE AIR/WATER (A/W) CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283174 ↗
• MalfunctionFeb 3, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD RESIDUE AROUND INSTRUMENT CHANNEL OUTLET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247393 ↗
• MalfunctionJan 21, 2026Device Reprocessing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133671 ↗
• MalfunctionJan 7, 2026Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995420 ↗
• MalfunctionJan 5, 2026No Flow

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A PIECE OF BRUSH STUCK IN THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955994 ↗
• MalfunctionDec 26, 2025Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A FOGGY AND BLURRY IMAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896505 ↗
• MalfunctionDec 22, 2025Residue After Decontamination; Failure to Clean Adequately; Residue After Decontamination; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865801 ↗
• MalfunctionDec 10, 2025Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767158 ↗
• MalfunctionNov 17, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A DITY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571869 ↗
• MalfunctionAug 21, 2025Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE'S IMAGE WAS BLURRY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862473 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE SUBJECT DEVICE HAD GREEN FLUID COMING FROM THE TIP. THIS ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687543 ↗
• MalfunctionNov 15, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD A DEFECTIVE AIR OR WATER DUCT. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE NOZZLE WAS FOUND CLOGGED WITH FOREIGN MATERIAL RESEMBLING A BLACK RUBBER. 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 18142136 ↗
• MalfunctionNov 6, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD AIR/WATER LEAKAGE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND AT THE AIR/WATER TUBE AND AIR/WATER CYLINDER. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081196 ↗
• MalfunctionSep 28, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD LOOSE AND POOR ANGLES. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FOREIGN MATERIALS WERE FOUND AT THE SCOPE CONNECTOR, DISTAL END, OBJECTIVE LENSES, AND NOZZLE OF THE DEVICE. 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 17840844 ↗
• MalfunctionJun 28, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE BIOPSY CHANNEL ON THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE MAY HAVE BEEN TORN AS SOME BLACK MATERIALS WERE COMING OUT THE SCOPE. THE ISSUE WAS FOUND DURING MAINTENANCE IN THE REPROCESSING ROOM. NO REPORTED PATIENT HARM INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841684 ↗
• MalfunctionJan 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, ¿THERE WAS A TEAR NEAR THE END AND EXPOSED WIRES¿ ON THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353159 ↗