EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2T160 (UDI 04953170307492)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170307492), received between Jul 5, 2020 and Mar 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THEY OBSERVED A LEAKAGE FROM THE INSTRUMENT CHANNEL, ANGULATION PLAY IN ALL DIRECTIONS, LOOSE ANGULATION KNOB, AND WRINKLES ON THE CONNECTING TUBE. 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 16642310 ↗
• MalfunctionDec 22, 2022Device Reprocessing Problem; Device Reprocessing Problem

  COMPANY REPRESENTATIVE SENT REPAIR REQUEST REPORTED WITH AN ISSUE OF "CHEMICAL ADHESION" . THE ISSUE FOUND DURING AN UNKNOWN EVENT. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE EVALUATION FOUND THE DEVICE CONNECTING TUBE HAS FOREIGN MATERIAL . THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATTER ADHERED (PROBLEMS RELATED TO REPROCESSING, INSUFFICIENT REPROCESSING ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040378 ↗
• MalfunctionJul 5, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. INSTRUMENT CHANNEL: FUNGAL HYPHAE (>20 CFU/ENDOSCOPE), BACILLUS SPECIES (>20 CFU/ENDOSCOPE), COAGULASE-NEGATIVE STAPHYLOCOCCI (>20 CFU/ENDOSCOPE) THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE USA), USING GLUTARALDEHYDE. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230998 ↗