EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N (UDI 04953170307515)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170307515), received between Jan 14, 2021 and May 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (4 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A CORRODED ADHESIVE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068711 ↗
• MalfunctionJan 6, 2026Crack; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A CRACKED CHARGED COUPLE DEVICE UNIT WITH POOR IMAGE QUALITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976085 ↗
• MalfunctionNov 19, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL AT THE AIR/WATER (A/W) TUBE AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600483 ↗
• MalfunctionMay 28, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER. AIR/WATER TUBE, AND NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095359 ↗
• MalfunctionApr 30, 2025Device Reprocessing Problem; Device Reprocessing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933908 ↗
• MalfunctionFeb 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD FOREIGN MATERIAL ON THE PLASTIC DISTAL END COVER AND ADHESIVE OF THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669228 ↗
• MalfunctionDec 18, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE EXPERIENCED WRINKLES IN THE CONNECTING TUBE. THE ISSUE WAS FOUND DURING CUSTOMER MAINTENANCE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE AIR WATER NOZZLE. 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 18345063 ↗
• MalfunctionMar 22, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING PREPARATION FOR USE THEY DISCOVERED THAT THE BENDING SECTION COVER WAS DEFORMED, AND THE DEGREE OF ANGULATION WAS ABNORMAL. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE FOLLOWING WAS FOUND: THE ENDOSCOPIC IMAGE WAS BLURRED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (THE ENDOSCOPIC IMAGE WAS BLURRED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592020 ↗
• MalfunctionJan 11, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE DISPLAYED A BLURRY IMAGE. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137262 ↗
• MalfunctionDec 13, 2022Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED AN ANGULATION PROBLEM WITH THE SUBJECT DEVICE. THERE WAS NO CLINICAL IMPACT OR INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE OBSERVED A BLURRY IMAGE. THIS REPORT IS BEING SUBMITTED FOR THE BLURRY IMAGE FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965960 ↗
• MalfunctionNov 3, 2021Microbial Contamination of Device; Microbial Contamination of Device

  AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE (B)(4) OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749612 ↗
• MalfunctionJan 14, 2021Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, UNSPECIFIED MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11175436 ↗