GASTROINTESTINAL FIBERSCOPE OLYMPUS GIF TYPE E3 (UDI 04953170152443)Recalls & reported problems

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170152443), received between May 27, 2026 and Sep 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (1 report).

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 Adequately1
Overheating of Device1
Poor Quality Image1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 23, 2026Overheating of Device; Failure to Clean Adequately
The customer returned the gastrointestinal fiberscope to the service center for maintenance with no complaint.. During the initial evaluation of the returned device, the forceps channel was found to be clogged with melted cap material. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870398 ↗
MalfunctionMay 27, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, BLURRY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298979 ↗

Device details

UDI-DI	`04953170152443`
Brand	GASTROINTESTINAL FIBERSCOPE
Model	OLYMPUS GIF TYPE E3
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 fibreoptic 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 the device which can be end-viewing (looking forward) or side-viewing (looking to one side) through a fibreoptic bundle and it 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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