EVIS EXERA GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE 2T160 (UDI 04953170066610)Recalls & reported problems

Olympus Medical Systems Corp. · GIF-2T160 THERAPEUTIC VIDEO GASTROSCOPE · Class 2

All models of EVIS EXERA GASTROINTESTINAL VIDEOSCOPE (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus GIF-2T160 therapeutic video gastroscope is a flexible scope used to examine and treat the stomach and upper digestive tract. Most of the 32 reports describe cleaning and reprocessing problems — residue, black or red material, mold and bacteria found inside the air/water nozzle or channels, along with a few images that failed to appear. None report a death or an injury. There are no recalls name this device, and reports in the last 12 months, at 16, were about twice the 8 in the prior year.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 32
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04953170066610), received between Jun 13, 2018 and Jun 8, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (11 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Clean Adequately11
Microbial Contamination of Device4
Device Reprocessing Problem3
Poor Quality Image3
Residue After Decontamination3
Erratic or Intermittent Display2
Melted2
No Display/Image2

Patient problems

No Clinical Signs, Symptoms or Conditions29
No Consequences Or Impact To Patient2
Insufficient Information1

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434067 ↗
MalfunctionMay 13, 2026Failure to Clean Adequately
THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO OLYMPUS WITH A REPORTED COMPLAINT OF FAILED LEAK TEST THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER, THERE WERE FOREIGN MATERIALS COMING OUT OF THE DISTAL END OF THE GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162465 ↗
MalfunctionMay 5, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD BLACK FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084546 ↗
MalfunctionApr 17, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE NOZZLE OF THE GASTROINTESTINAL VIDEOSCOPE HAD RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910139 ↗
MalfunctionApr 9, 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 24827296 ↗
MalfunctionMar 12, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A RED SUBSTANCE ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578828 ↗
MalfunctionFeb 6, 2026Microbial Contamination of Device
IT WAS REPORTED THAT DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR >100 COLONY FORMING UNITS (CFU) OF CITROBACTER FREUNDII, GRAM-NEGATIVE BACILLI OF THE ENTEROBACTERIACEAE FAMILY, AND MOLDS. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281608 ↗
MalfunctionJan 22, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151446 ↗
MalfunctionDec 29, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918837 ↗
MalfunctionDec 23, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITE RESIDUE IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882753 ↗
MalfunctionDec 12, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CHEMICAL RESIDUE IN THE AUXILIARY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23791144 ↗
MalfunctionDec 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE OBJECT STUCK INSIDE THE SCOPE, THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769610 ↗
MalfunctionDec 9, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROVIDEOSCOPE IMAGE-EVIS EXHIBITED INTERMIT/FLICKER IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23753217 ↗
MalfunctionDec 8, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752574 ↗
MalfunctionDec 2, 2025Erratic or Intermittent Display; Poor Quality Image; Erratic or Intermittent Display; Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLURRY AND FLICKERING IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697583 ↗
MalfunctionNov 19, 2025Melted; Melted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE'S CAMERA COVER WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596603 ↗
MalfunctionOct 28, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A LARGE AMOUNT OF GLUE ON THE PLASTIC DISTAL END COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405598 ↗
MalfunctionSep 9, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE WAS OBSERVED TO HAVE FOREIGN OBJECT STUCK INSIDE THE BIOPSY CHANNEL MOUNT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23010561 ↗
MalfunctionAug 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD SUTURE STUCK IN SCOPE. THE EVENT HAD OCCURRED DURING THE THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22683864 ↗
MalfunctionJul 10, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THE SUBJECT DEVICE HAD SOMETHING STUCK IN THE CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473292 ↗
MalfunctionJun 26, 2025Melted; Failure to Clean Adequately; Melted; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE AIR-WATER CHANNEL AND THE JET TUBE, ALSO THE CAMERA COVER WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341361 ↗
MalfunctionJun 4, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE UNIVERSAL CORD WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140423 ↗
MalfunctionMay 27, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE WAS TRANSPORTED IN A BUCKET THAT CONTAINED A SIGNIFICANT AMOUNTS OF WATER WITH NO CAP IN PLACE. THIS OCCURRED WHILE THE SCOPE WAS BEING CLEANED AT THE BEDSIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087456 ↗
MalfunctionMay 12, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING DEVICE REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED BLACK RESIDUE LEAKING FROM THE DISTAL END OF SCOPE AFTER HIGH-LEVEL DISINFECTION (HDL) PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003254 ↗
MalfunctionJul 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE FLEX VIDEO SCOPE EXHIBITED CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822246 ↗

Device details

UDI-DI	`04953170066610`
Brand	EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
Model	OLYMPUS GIF TYPE 2T160
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 12, 2024

Device type (GMDN): Flexible video gastroduodenoscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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