EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q160ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170066795), received between Apr 23, 2024 and May 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE HAD A BLURRY IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077522 ↗
• MalfunctionApr 1, 2025Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE CHALLENGE OF ENDOSCOPE REPROCESSING DELAYS." THIS STUDY REPRESENTS A NOVEL APPROACH TO ADDRESS DELAYS IN ENDOSCOPE REPROCESSING, PARTICULARLY IN POST-EMERGENCY AND POST-URGENCY CASES. DURING A DEPARTMENTAL MEETING, WE SOUGHT TO IDENTIFY NEW METHODS TO ENSURE FASTER AND MORE EFFECTIVE REPROCESSING IN THESE CRITICAL SCENARIOS. FOR THE FIRST TIME IN THE LITERATURE, WE PROPOSED THE USE OF DUCK BAGS (DBS) AS A POTENTIAL SOLUTION TO THE CHALLENGES OF ENDOSCOPY MATERIAL REPROCESSING. DB IS A DEVICE TRADITIONALLY EMPLOYED IN OPERATING ROOMS FOR MAINTAINING A SAFE AND SEALED HUMID ENVIRONMENT FOR CONTAMINATED SURGICAL INSTRUMENTS, WITH PROPERTIES PREVENTING THE DRYING OF ORGANIC MATERIAL ON BOTH INTERNAL AND EXTERNAL SURFACES, ENSURING GREATER EFFECTIVENESS OF SUBSEQUENT CLEANING AND DISINFECTION PROCESSES. THE AIM WAS TO EVALUATE THE EFFECTIVENESS OF DBS IN PRESERVING ENDOSCOPES BETWEEN PRECLEANING AND REPROCESSING. SPECIAL CONSIDERATION WAS GIVEN TO DEFINE OPTIMAL CONSERVATION TIMING, AS THE MANUFACTURER DOES NOT SPECIFY A STORAGE TIME LIMIT. WE HYPOTHESIZED THAT THESE BAGS, ALREADY PROVEN EFFECTIVE IN MAINTAINING INSTRUMENT INTEGRITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740063 ↗
• MalfunctionMay 3, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BEEN REPROCESSED WITH AN ENDOSCOPE REPROCESSOR IN WHICH THE WATER FILTER REPLACEMENT DEADLINE HAD EXPIRED BY TWO YEARS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237803 ↗
• MalfunctionApr 23, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE VIDEOSCOPE HAD A FOGGY LENS AND BLURRY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166644 ↗